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| Name | Class |
|---|---|
| The Peanut Institute | OTHER |
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A two-period randomized crossover study will be conducted to determine the effect of peanuts on glycemic control, and elucidate the role of the microbiome in glucose regulation, in individuals with impaired fasting glucose.
A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 6 weeks followed by a minimum 4-week wash-out period. During the peanut treatment, participants will consume one ounce per day (28 g) of peanuts as an evening snack. The control treatments will be an isocaloric higher carbohydrate snack consumed after the evening meal. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evening Peanut Consumption | Experimental | Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep). |
|
| Evening Snack | Active Comparator | Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut | Drug | Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose | Within-condition mean differences (change from baseline). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fructosamine | Within-condition mean differences (change from baseline). | 6 weeks |
| Fasting Insulin | Within-condition mean differences (change from baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Penny M Kris-Etherton, PhD | Penn State University | Principal Investigator |
| Kristina S Petersen, PhD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania State University | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34562081 | Derived | Sapp PA, Kris-Etherton PM, Petersen KS. Peanuts or an Isocaloric Lower Fat, Higher Carbohydrate Nighttime Snack Have Similar Effects on Fasting Glucose in Adults with Elevated Fasting Glucose Concentrations: a 6-Week Randomized Crossover Trial. J Nutr. 2022 Jan 11;152(1):153-162. doi: 10.1093/jn/nxab347. |
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51 participants were randomized. One participant withdrew from study before receiving either intervention
267 participants were screened for eligibility
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| ID | Title | Description |
|---|---|---|
| FG000 | Evening Peanut Consumption - Evening Snack Sequence | First intervention: Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep). Peanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume. Second intervention: Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep). High carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine). |
| FG001 | Evening Snack-Evening Peanut Consumption Sequence | First intervention: Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep). High carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine). Second intervention: Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep). Peanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (6 Weeks) |
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| Washout Period (2-weeks) |
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| Second Intervention (6 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Evening Peanut Consumption-Evening Snack Sequence | First intervention: Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep). Peanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume. Second Intervention: Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep). High carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Plasma Glucose | Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 6 weeks |
|
|
All 16-wks of trial
No subjects were at risk for serious adverse event or all-cause mortality. Therefore, these were not monitored. Adverse-events (e.g., allergic reactions to study foods) were monitored.
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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 | Evening Peanut Consumption | Evening Peanut Consumption | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Penny Kris-Etherton | The Pennsylvania State University | 814-863-2923 | pmk3@psu.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 | Sep 4, 2019 | Sep 20, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 28, 2018 | Sep 20, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| High carbohydrate snack | Drug | Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine). |
|
| 6 weeks |
| Peripheral Systolic and Diastolic Blood Pressure | Within-condition mean differences (change from baseline). | 6 weeks |
| Central Systolic and Diastolic Blood Pressure | Within-condition mean differences (change from baseline). | 6 weeks |
| Carotid Femoral Pulse Wave Velocity | Carotid-femoral pulse wave velocity is a measure of arterial stiffness and is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. Within-condition mean differences (change from baseline). | 6 weeks |
| Augmentation Index (%) | A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness Within-condition mean differences (change from baseline). | 6 weeks |
| LDL Cholesterol | Within-condition mean differences (change from baseline). | 6 weeks |
| HDL Cholesterol | Within-condition mean differences (change from baseline). | 6 weeks |
| Total Cholesterol | Within-condition mean differences (change from baseline). | 6 weeks |
| Triglycerides | Within-condition mean differences (change from baseline). | 6 weeks |
| Body Weight | Within-condition mean differences (change from baseline). | 6 weeks |
| Microbiota Alpha-diversity | Measured by Faith's Phylogenetic Diversity Score. This is a measure of biodiversity (based on phylogeny). Faith's phylogenetic diversity measures the amount of the phylogenetic tree covered by the bacterial community. It's a sum of the minimum branch lengths. A higher number (more branches), means more richness (more diversity). Increases in Faith's Phylogenetic Diversity is indicative of more richness and diversity but no standard reference range or clinically relevant values have been established. Presented as endpoint mean values with IQR | 6 weeks |
| NOT COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Evening Snack-Evening Peanut Consumption Sequence | First Intervention: Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep). High carbohydrate snack: Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine). Second Intervention: Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep). Peanut: Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Fructosamine | Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | umol/L | 6 weeks |
|
|
|
|
| Secondary | Fasting Insulin | Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | umol/L | 6 weeks |
|
|
|
|
| Secondary | Peripheral Systolic and Diastolic Blood Pressure | Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | 6 weeks |
|
|
|
|
| Secondary | Central Systolic and Diastolic Blood Pressure | Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | 6 weeks |
|
|
|
|
| Secondary | Carotid Femoral Pulse Wave Velocity | Carotid-femoral pulse wave velocity is a measure of arterial stiffness and is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | m/s | 6 weeks |
|
|
|
|
| Secondary | Augmentation Index (%) | A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | % adjusted to a HR of 75 BPM | 6 weeks |
|
|
|
|
| Secondary | LDL Cholesterol | Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 6 weeks |
|
|
|
|
| Secondary | HDL Cholesterol | Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 6 weeks |
|
|
|
|
| Secondary | Total Cholesterol | Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 6 weeks |
|
|
|
|
| Secondary | Triglycerides | Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 6 weeks |
|
|
|
|
| Secondary | Body Weight | Within-condition mean differences (change from baseline). | Posted | Least Squares Mean | 95% Confidence Interval | kg | 6 weeks |
|
|
|
|
| Secondary | Microbiota Alpha-diversity | Measured by Faith's Phylogenetic Diversity Score. This is a measure of biodiversity (based on phylogeny). Faith's phylogenetic diversity measures the amount of the phylogenetic tree covered by the bacterial community. It's a sum of the minimum branch lengths. A higher number (more branches), means more richness (more diversity). Increases in Faith's Phylogenetic Diversity is indicative of more richness and diversity but no standard reference range or clinically relevant values have been established. Presented as endpoint mean values with IQR | Posted | Median | Inter-Quartile Range | Faith's Phylogenetic Diversity Score | 6 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 50 |
| EG001 | Evening Lower-Fat Higher-Carbohydrate Snack | Evening Lower-Fat Higher-Carbohydrate Snack | 0 | 0 | 0 | 0 | 0 | 50 |
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| Mean Difference (Final Values) |
| -4 |
| 2-Sided |
| 95 |
| -5.1 |
| 5.4 |
| Other |
change from baseline |
| Mixed Models Analysis | Mean Difference (Final Values) | -3.8 | 2-Sided | 95 | -5.1 | 5.4 | Other | change from baseline |
| Mean Difference (Final Values) |
| -0.2 |
| 2-Sided |
| 95 |
| -1.5 |
| 1.0 |
| Other |
change from baseline |
| Mixed Models Analysis | Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | -2.1 | 0.5 | Other | change from baseline |
| Mean Difference (Final Values) |
| 0.4 |
| 2-Sided |
| 95 |
| -2.1 |
| 2.9 |
| Superiority |
| peripheral systolic BP change from baseline | Mixed Models Analysis | Mean Difference (Final Values) | 0.4 | 2-Sided | 95 | -2.5 | 3.3 | Other | change from baseline |
| peripheral systolic BP change from baseline | Mixed Models Analysis | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -3.1 | 2.6 | Other | change from baseline |
| peripheral diastolic BP change from baseline | Mixed Models Analysis | Mean Difference (Final Values) | 0.5 | 2-Sided | 95 | -1.5 | 2.5 | Other | change from baseline |
| peripheral diastolic BP change from baseline | Mixed Models Analysis | Mean Difference (Final Values) | -0.0 | 2-Sided | 95 | -2 | 2 | Other | change from baseline |
| Mean Difference (Final Values) |
| 0.8 |
| 2-Sided |
| 95 |
| -1.7 |
| 3.3 |
| Superiority |
| central systolic BP change from baseline | Mixed Models Analysis | Mean Difference (Final Values) | 0.6 | 2-Sided | 95 | -1.9 | 3.1 | Other | change from baseline |
| central systolic BP change from baseline | Mixed Models Analysis | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -2.9 | 2.1 | Other | change from baseline |
| central diastolic BP change from baseline | Mixed Models Analysis | Mean Difference (Final Values) | 0.5 | 2-Sided | 95 | -1.5 | 2.6 | Other | change from baseline |
| central diastolic BP change from baseline | Mixed Models Analysis | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -2.4 | 1.6 | Other | change from baseline |
| Mean Difference (Final Values) |
| 0.3 |
| 2-Sided |
| 95 |
| 0.1 |
| 0.6 |
| Other |
change from baseline |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.1 | 0.3 | Other | change from baseline |
| Mean Difference (Final Values) |
| -0.4 |
| 2-Sided |
| 95 |
| -3.7 |
| 2.9 |
| Other |
change from baseline |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.2 | 2-Sided | 95 | -4.0 | 4.3 | Other | change from baseline |
| Mean Difference (Final Values) |
| 2.4 |
| 2-Sided |
| 95 |
| -2.1 |
| 6.9 |
| Other |
change from baseline |
| Mixed Models Analysis | Mean Difference (Final Values) | -2.3 | 2-Sided | 95 | -6.8 | 2.2 | Other | change from baseline |
| Mean Difference (Final Values) |
| 0.6 |
| 2-Sided |
| 95 |
| -0.6 |
| 1.8 |
| Other |
change from baseline |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.6 | 2-Sided | 95 | -1.6 | 2.3 | Other | change from baseline |
| Mean Difference (Final Values) |
| 0.1 |
| 2-Sided |
| 95 |
| -4.9 |
| 5.1 |
| Other |
change from baseline |
| Mixed Models Analysis | Mean Difference (Final Values) | -2.7 | 2-Sided | 95 | -7.8 | 2.3 | Other | change from baseline |
| Mean Difference (Final Values) |
| -17 |
| 2-Sided |
| 95 |
| -29.1 |
| -4.8 |
| Other |
change from baseline |
| Mixed Models Analysis | Mean Difference (Final Values) | -5.7 | 2-Sided | 95 | -17.1 | 5.7 | Other | change from baseline |
| Mean Difference (Final Values) |
| 0.2 |
| 2-Sided |
| 95 |
| -0.1 |
| 1.5 |
| Other |
change from baseline |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.5 | 0.5 | Other | change from baseline |