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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL137716 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Touro University, California | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The objectives of this proposal are to address the gaps in knowledge regarding the metabolic effects of consuming orange juice, the most frequently consumed fruit juice in this country, compared to sugar-sweetened beverage.
Specific Aims: There is considerable epidemiological evidence that demonstrates associations between added sugar/sugar-sweetened beverage consumption and increased risk for or prevalence of chronic diseases such as cardiovascular disease (CVD), type 2 diabetes (T2D), metabolic syndrome, and gout. Especially concerning is recent evidence from National Health and Nutrition Examination Survey III that demonstrates that there is increased risk of CVD mortality with increased intake of added sugar across quintiles (Yang, 2014). Even the US mean added sugar intake, 15% of daily calories, was associated with an 18% increase in risk of CVD mortality over 15 years. The results from the investigator's recently completed study (1R01 HL09133) corroborate these findings (Stanhope, 2015). They demonstrate that supplementing the ad libitum diets of young adults with beverages containing 0, 10, 17.5 or 25% of daily energy requirement (Ereq) as high fructose corn syrup (HFCS) affects lipid/lipoprotein risk factors for CVD in a dose response manner. Specifically, levels of nonHDL-cholesterol(C), LDL-C, apolipoprotein B (apoB), and postprandial triglycerides (TG) increased linearly over a 2-week period with increasing doses of HFCS. Furthermore, even the participants consuming the 10% Ereq dose exhibited increased levels of these risk factors compared to baseline.
These and similar results have helped to lead to reductions in soda consumption in this country, and new dietary guidelines and FDA food labeling requirements to promote reductions in added sugar consumption. However, there are gaps in knowledge about other sugar-containing foods that lead to public confusion concerning healthier options for soda, and impede further progress in implementing public health policies that will promote further reductions in soda consumption. One such food is naturally-sweetened fruit juice. The amount of sugar in fruit juice is comparable to the amount in soda. Because of this, a consumer seeking answers on the internet will find many articles in which experts state or suggest that the effects of consuming fruit juice are as detrimental as or even worse than those of soda. However, in contrast to soda, fruit juice contains micronutrients and bioactives that may promote health. Therefore the consumer can also find numerous articles on the internet where the health benefits of fruit juice and these bioactives are extolled. There are a limited number of clinical dietary intervention studies that have directly compared the metabolic effects of consuming fruit juice and sugar-sweetened beverage, and their results are not conclusive. Thus we will pursue the following Specific Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naturally-sweetened orange juice | Experimental | Naturally-sweetened orange juice Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks |
|
| Sugar-sweetened beverage | Active Comparator | Sugar-sweetened beverage Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naturally-sweetened orange juice | Other | Commercially-available ready-to-serve refrigerated orange juice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Low Density Lipoprotein Cholesterol (LDL-C) | Absolute change of plasma LDL-C concentration (4 week value - 0 week value) | 4 weeks |
| Postprandial Low Density Lipoprotein Cholesterol (LDL-C) | Absolute change of plasma postprandial LDL-C concentration (4 week value - 0 week value) | 4 weeks |
| Fasting Apolipoprotein B (apoB) | Absolute change of plasma apoB concentration (4 week value - 0 week value) | 4 weeks |
| Postprandial Apolipoprotein B (apoB) | Absolute change of plasma postprandial apoB concentration (4 week value - 0 week value) | 4 weeks |
| Fasting Uric Acid | Absolute change of plasma uric acid concentration (4 week value - 0 week value) | 4 weeks |
| Postprandial Uric Acid | Absolute change of post-dinner 4-hour AUC plasma uric acid concentration (4 week value - 0 week value) | 4 weeks |
| Fasting Apolipoprotein CIII (apoCIII) | Absolute change of fasting plasma apoCIII concentration (4 week value - 0 week value) | 4 weeks |
| Postprandial Apolipoprotein CIII (apoCIII) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Triglyceride | Absolute change of plasma fasting triglyceride concentration (4 week value - 0 week value) | 4 weeks |
| 3-(3'-Hydroxy-4'-Methoxyphenyl)Hydracrylic | Absolute change of total 24-hour urinary 3-(3'-hydroxy-4'-methoxyphenyl)hydracrylic (4 week value - 0 week value) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Insulin | Absolute change serum insulin concentration (4-week value - 0-week value) | 4 week |
| Fasting Glucose | Absolute change in fasting plasma glucose concentration (4-week value - 0-week value) |
Inclusion Criteria: men and pre-menopausal women Body mass index: 20-35 kg/m2 Body weight > than 50 kg Self-reported stable body weight during the prior six months
Exclusion Criteria:
Fasting glucose >125 mg/dl Evidence of liver disorder (AST or ALT >200% upper limit of normal range) Evidence of kidney disorder (>2.0 mg/dl creatinine) Evidence of thyroid disorder (out of normal range) Systolic blood pressure consistently over 140 mmHg or diastolic blood pressure over 90 mmHg Triglycerides > 400 mg/dl LDL-C > 160 mg/dl in combination with Chol:HDL > 4 Hemoglobin < 10 g/dL Pregnant or lactating women Current, prior (within 12 months), or anticipated use of any hypolipidemic or anti-diabetic agents.
Use of thyroid, anti-hypertensive, anti-depressant, weight loss medications or any other medication which, in the opinion of the investigator, may confound study results Use of tobacco Strenuous exerciser (>3.5 hours/week at a level more vigorous than walking) Surgery for weight loss Diet exclusions: Food allergies, special dietary restrictions, routine consumption of less than 3 meals/day, routine ingestion of more than 2 sugar-sweetened beverages or 1 alcoholic beverage/day, unwillingness to consume any food on study menu Veins that are assessed by the R.N.s as being unsuitable for long-term infusions and multiple blood draws from a catheter.
Pre-existing claustrophobia or metal implants that preclude magnetic resonance imaging Any other condition that, in the opinion of the investigators, would put the subject at risk
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self-representation
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| Name | Affiliation | Role |
|---|---|---|
| Kimber L Stanhope, Ph.D. | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Davis | California | 95616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24493081 | Result | Yang Q, Zhang Z, Gregg EW, Flanders WD, Merritt R, Hu FB. Added sugar intake and cardiovascular diseases mortality among US adults. JAMA Intern Med. 2014 Apr;174(4):516-24. doi: 10.1001/jamainternmed.2013.13563. | |
| 25904601 | Result | Stanhope KL, Medici V, Bremer AA, Lee V, Lam HD, Nunez MV, Chen GX, Keim NL, Havel PJ. A dose-response study of consuming high-fructose corn syrup-sweetened beverages on lipid/lipoprotein risk factors for cardiovascular disease in young adults. Am J Clin Nutr. 2015 Jun;101(6):1144-54. doi: 10.3945/ajcn.114.100461. Epub 2015 Apr 22. |
| Label | URL |
|---|---|
| Learn more or sign up for the study here! | View source |
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Final dataset will include data collected specifically for the study and data provided during screening in the medical history form. This includes some demographic information and data regarding family history of disease. We will make data and demographic information available to other investigators upon request. The dataset will be stripped of all unique identifiers and subject characteristics and prepared in accordance with all HIPAA regulations prior to release for sharing. Study outcome results will be submitted to ClinicalTrials.gov no later than one year after the trial's primary completion date.
One year after the end of study--January 31, 2025
We will make data and demographic information available to investigators who submit an outline with:
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| ID | Title | Description |
|---|---|---|
| FG000 | Naturally-sweetened orange juice | Naturally-sweetened orange juice Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks Naturally-sweetened orange juice: Commercially-available ready-to-serve refrigerated orange juice |
| FG001 | Sugar-sweetened beverage | Sugar-sweetened beverage Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks Sugar-sweetened beverage: Sugar-sweetened water flavored with Kool-Aid (TM) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naturally-sweetened orange juice | Naturally-sweetened orange juice Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks Naturally-sweetened orange juice: Commercially-available ready-to-serve refrigerated orange juice |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fasting Low Density Lipoprotein Cholesterol (LDL-C) | Absolute change of plasma LDL-C concentration (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | mg/dl | 4 weeks |
|
Adverse events for each participant were collected for 6 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naturally-sweetened orange juice | Naturally-sweetened orange juice Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks Naturally-sweetened orange juice: Commercially-available ready-to-serve refrigerated orange juice |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stomachache | Gastrointestinal disorders | Non-systematic Assessment | indigestion due to fiber or orange juice in study diet |
It is a limitation of the trial that we did not achieve the diversity of race/ethnicity that we had planned. Due to the COVID epidemic most of our participants were University of California Davis students. Thus our demographics reflect the UC Davis student population and 63% of the participants were Asian.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimber Stanhope | University of California, Davis | 5302190914 | klstanhope@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2022 | May 27, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2022 | May 27, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000080845 | Sugar-Sweetened Beverages |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Randomized controlled trial
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All outcomes will be analyzed/assessed by subject identity number, which are assigned prior to randomization to experimental arm.
| Sugar-sweetened beverage | Other | Sugar-sweetened water flavored with Kool-Aid (TM) |
|
Absolute change of plasma postprandial apoCIII concentration (4 week value - 0 week value)
| 4 weeks |
| Postprandial Triglyceride | Absolute change of 4-h post-dinner AUC plasma triglyceride concentration (4 week value - 0 week value) | 4 weeks |
| Hepatic Triglyceride | Absolute change of % hepatic triglyceride (4 week value - 0 week value) | 4 weeks |
| Matsuda Insulin Sensitivity Index (ISI) | Absolute change of Matsuda ISI (4 week value - 0 week value). The Matsuda Index is a ratio of glucose and insulin levels during oral glucose tolerance test. It is calculated using fasting and mean glucose and insulin measurements, but the units of these measurements cancel out in the formula. A Matsuda value less than 2.5 may indicate insulin resistance, thus a lowering of the Matsuda index is a detrimental outcome. At baseline the Matsuda index in the participants for which it was assessed ranged from 1.4 to 7.8 (mean = 3.7, standard deviation = 1.6). | 4 week |
| Postprandial de Novo Lipogenesis | Absolute change of 8-hour area under the curve (AUC) percentage fractional rate postprandial de novo lipogenesis DNL (4 week value - 0 week value) | 4 weeks |
| M Value During Hyperinsulinemic Euglycemic Clamp | Absolute change of M value (glucose infusion rate during final 30 minute steady state)/ fat free body mass (kg) (4 week value - 0 week value) | 4 weeks |
| 4 weeks |
| Hesperetin-3'-O-glucuronide | Absolute change of total 24-hour urinary hesperetin-3'-O-glucuronide (4 week value - 0 week value)Urine concentration hesperetin-3'-O-glucuronide | 4 weeks |
| Hesperetin-3',7-0-diglucuronide | Absolute change of total 24-hour urinary hesperetin-3',7-0-diglucuronide (4 week value - 0 week value) | 4 weeks |
| p-Hydroxyhippuric Acid | Absolute change of total 24-hour urinary p-Hydroxyhippuric acid (4 week value - 0 week value) | 4 weeks |
| 3-(4'-Methoxyphenyl)Propionic Acid-3'-O-glucuronide | Absolute change of total 24-hour urinary 3-(4'-methoxyphenyl)propionic acid-3'-O-glucuronide (4 week value - 0 week value) | 4 weeks |
| Hesperetin-7-O-glucuronide | Absolute change of total 24-hour urinary hesperetin-7-O-glucuronide (4 week value - 0 week value) | 4 weeks |
| Naringin-7-O-glucuronide | Absolute change of total 24-hour urinary naringen-7-O-glucuronide (4 week value - 0 week value) | 4 weeks |
| Oral Glucose Tolerance Test (OGTT) Glucose 3-hour Area Under the Curve (AUC) | Absolute change in OGTT 3-hour AUC glucose concentration (4-week value - 0-week value) | 4 week |
| Oral Glucose Tolerance Test (OGTT) Insulin 3-hour Area Under the Curve | Absolute change in OGTT 3-hour AUC insulin concentration (4-week value - 0-week value) | 4 week |
| Fasting de Novo Lipogenesis | Absolute change of fasting percentage fractional rate fasting de novo lipogenesis DNL (4 week value - 0 week value) | 4 weeks |
| glucose |
| Body Weight | Change in body weight (4-week value - 0-week value) | 4 weeks |
| Systolic Blood Pressure | Change in systolic blood pressure (4-week value - 0-week value) | 4 weeks |
| Diastolic Blood Pressure | Change in diastolic blood pressure (4-week value minus 0-week value) | 4 weeks |
| Body Fat | %body fat | 4 weeks |
| Withdrawn by PI due to dietary miscompliance |
|
| Sugar-sweetened beverage |
Sugar-sweetened beverage Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks Sugar-sweetened beverage: Sugar-sweetened water flavored with Kool-Aid (TM) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Body Weight (kg)/(Height (meters))*(Height (meters)) | Mean | Standard Deviation | kg/meters^2 |
|
| Systolic blood pressure | Systolic blood pressure during fasting (mmHg) | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Systolic blood pressure during fasting (mmHg) | Mean | Standard Deviation | mmHg |
|
Sugar-sweetened beverage Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks Sugar-sweetened beverage: Sugar-sweetened water flavored with Kool-Aid (TM) |
|
|
|
| Primary | Postprandial Low Density Lipoprotein Cholesterol (LDL-C) | Absolute change of plasma postprandial LDL-C concentration (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. Unable to collect week 4 postprandial samples from one participant in the Sucrose Group | Posted | Mean | Standard Deviation | mg/dl | 4 weeks |
|
|
|
|
| Primary | Fasting Apolipoprotein B (apoB) | Absolute change of plasma apoB concentration (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | mg/dl | 4 weeks |
|
|
|
|
| Primary | Postprandial Apolipoprotein B (apoB) | Absolute change of plasma postprandial apoB concentration (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. Unable to collect post-dinner blood samples from one participant in the sucrose group during the 4-week intervention trial. | Posted | Mean | Standard Deviation | mg/dl | 4 weeks |
|
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|
|
| Primary | Fasting Uric Acid | Absolute change of plasma uric acid concentration (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | mg/dl | 4 weeks |
|
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|
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| Primary | Postprandial Uric Acid | Absolute change of post-dinner 4-hour AUC plasma uric acid concentration (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. Unable to collect post-dinner blood samples from one participant in the sucrose group during the 4-week intervention trial. | Posted | Mean | Standard Deviation | mg/dl x 4 h | 4 weeks |
|
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|
| Primary | Fasting Apolipoprotein CIII (apoCIII) | Absolute change of fasting plasma apoCIII concentration (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | mg/dl | 4 weeks |
|
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| Primary | Postprandial Apolipoprotein CIII (apoCIII) | Absolute change of plasma postprandial apoCIII concentration (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. Unable to collect post-dinner blood samples from one participant in the sucrose group during the 4-week intervention trial. | Posted | Mean | Standard Deviation | mg/dl | 4 weeks |
|
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| Primary | Postprandial Triglyceride | Absolute change of 4-h post-dinner AUC plasma triglyceride concentration (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. Unable to collect post-dinner blood samples from one participant in the sucrose group during the 4-week intervention trial. | Posted | Mean | Standard Deviation | mg/dl x 4 h | 4 weeks |
|
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| Primary | Hepatic Triglyceride | Absolute change of % hepatic triglyceride (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. One participant in the Orange Juice Group was not able to attend the intervention MRI appointment. | Posted | Mean | Standard Deviation | % fat in liver | 4 weeks |
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| Primary | Matsuda Insulin Sensitivity Index (ISI) | Absolute change of Matsuda ISI (4 week value - 0 week value). The Matsuda Index is a ratio of glucose and insulin levels during oral glucose tolerance test. It is calculated using fasting and mean glucose and insulin measurements, but the units of these measurements cancel out in the formula. A Matsuda value less than 2.5 may indicate insulin resistance, thus a lowering of the Matsuda index is a detrimental outcome. At baseline the Matsuda index in the participants for which it was assessed ranged from 1.4 to 7.8 (mean = 3.7, standard deviation = 1.6). | This analysis includes participants enrolled after a coronavirus disease 2019 (COVID)-related protocol modification, who completed a 3-hour OGTT. These participants (n=39) did not undergo hyperinsulinemic euglycemic clamps. Final data collection and analysis for this population are complete. One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | units on a scale | 4 week |
|
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| Primary | Postprandial de Novo Lipogenesis | Absolute change of 8-hour area under the curve (AUC) percentage fractional rate postprandial de novo lipogenesis DNL (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. Unable to collect post-dinner blood samples from one participant in the sucrose group during the 4-week intervention trial. | Posted | Oct 2025 | Mean | Standard Deviation | %fractional rate x 8 h | 4 weeks |
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| Secondary | Fasting Triglyceride | Absolute change of plasma fasting triglyceride concentration (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | mg/dl | 4 weeks |
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| Secondary | 3-(3'-Hydroxy-4'-Methoxyphenyl)Hydracrylic | Absolute change of total 24-hour urinary 3-(3'-hydroxy-4'-methoxyphenyl)hydracrylic (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | ng | 4 weeks |
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| Secondary | Hesperetin-3'-O-glucuronide | Absolute change of total 24-hour urinary hesperetin-3'-O-glucuronide (4 week value - 0 week value)Urine concentration hesperetin-3'-O-glucuronide | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | ng | 4 weeks |
|
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| Secondary | Hesperetin-3',7-0-diglucuronide | Absolute change of total 24-hour urinary hesperetin-3',7-0-diglucuronide (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. Invalid results obtained for this outcome in one participant in the sucrose group. | Posted | Mean | Standard Deviation | ng | 4 weeks |
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| Secondary | p-Hydroxyhippuric Acid | Absolute change of total 24-hour urinary p-Hydroxyhippuric acid (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | ng | 4 weeks |
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| Secondary | 3-(4'-Methoxyphenyl)Propionic Acid-3'-O-glucuronide | Absolute change of total 24-hour urinary 3-(4'-methoxyphenyl)propionic acid-3'-O-glucuronide (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | ng | 4 weeks |
|
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| Secondary | Hesperetin-7-O-glucuronide | Absolute change of total 24-hour urinary hesperetin-7-O-glucuronide (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | ng | 4 weeks |
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| Secondary | Naringin-7-O-glucuronide | Absolute change of total 24-hour urinary naringen-7-O-glucuronide (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. Invalid results obtained for this outcome in one participant in the sucrose group. | Posted | Mean | Standard Deviation | ng | 4 weeks |
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| Secondary | Oral Glucose Tolerance Test (OGTT) Glucose 3-hour Area Under the Curve (AUC) | Absolute change in OGTT 3-hour AUC glucose concentration (4-week value - 0-week value) | This analysis includes participants enrolled after a COVID-related protocol modification, who completed a 3-hour OGTT. These participants (n=39) did not undergo hyperinsulinemic euglycemic clamps. Final data collection and analysis for this population are complete. One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | mg/dl x 3 hours | 4 week |
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| Secondary | Oral Glucose Tolerance Test (OGTT) Insulin 3-hour Area Under the Curve | Absolute change in OGTT 3-hour AUC insulin concentration (4-week value - 0-week value) | This analysis includes participants enrolled after a COVID-related protocol modification, who completed a 3-hour OGTT. These participants (n=39) did not undergo hyperinsulinemic euglycemic clamps. Final data collection and analysis for this population are complete. One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | microUnit/ml x 3 hours | 4 week |
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| Secondary | Fasting de Novo Lipogenesis | Absolute change of fasting percentage fractional rate fasting de novo lipogenesis DNL (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Oct 2025 | Mean | Standard Deviation | %fractional rate | 4 weeks |
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| Other Pre-specified | Fasting Insulin | Absolute change serum insulin concentration (4-week value - 0-week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | microUnit/ml | 4 week |
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| Other Pre-specified | Fasting Glucose | Absolute change in fasting plasma glucose concentration (4-week value - 0-week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | mg/dl | glucose |
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| Other Pre-specified | Body Weight | Change in body weight (4-week value - 0-week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | kg | 4 weeks |
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| Other Pre-specified | Systolic Blood Pressure | Change in systolic blood pressure (4-week value - 0-week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
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| Other Pre-specified | Diastolic Blood Pressure | Change in diastolic blood pressure (4-week value minus 0-week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
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| Other Pre-specified | Body Fat | %body fat | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. DEXA analyzer not available to scan 2 participants in orange juice group and 1 participant in sucrose group during baseline trial. | Posted | Mean | Standard Deviation | percentage of body fat | 4 weeks |
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| Primary | M Value During Hyperinsulinemic Euglycemic Clamp | Absolute change of M value (glucose infusion rate during final 30 minute steady state)/ fat free body mass (kg) (4 week value - 0 week value) | One participant was excluded due to extreme values that deviated from the mean by more than 2 standard deviations across multiple outcomes. The exclusion was based on protocol-defined criteria. Unable to collect post-dinner blood samples from one participant in the sucrose group during the 4-week intervention trial. | Posted | Oct 2025 | Mean | Standard Deviation | %fractional rate | 4 weeks |
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| 0 |
| 25 |
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Sugar-sweetened beverage | Sugar-sweetened beverage Form: Beverage Daily dosage: 25% of daily energy requirement Frequency: Divided into 3 servings/day Duration: 4 weeks Sugar-sweetened beverage: Sugar-sweetened water flavored with Kool-Aid (TM) | 0 | 24 | 0 | 24 | 0 | 24 |
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