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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The overall aim of the study is to compare the effects of three types of beverages - sugar-sweetened (SSB), artificially sweetened (ASB), and unsweetened (USB) - on cardiovascular disease (CVD) risk factors and body weight among young adults.
Consumption of sugar sweetened beverages (SSB) has been linked to obesity and, independent of body weight, risk for diabetes and cardiovascular disease. With rising public health awareness of these potential adverse effects, consumption of artificially sweetened beverages (ASB) has increased dramatically. These low-calorie products are marketed as "diet," with the implication that they promote weight loss and improved health. However, there are no long-term experimental studies of ASB and body weight or any other health outcome. Several recent prospective observational studies have linked intake of ASB to increased risk of the metabolic syndrome, type 2 diabetes, and obesity. In the proposed clinical trial, 270 young adults who habitually consume SSB will be randomly assigned to one of three groups: 1) to continue consuming habitual levels of SSB; 2) to substitute ASB for SSB; or 3) to substitute unsweetened beverages for SSB. Each group will receive home delivery of the targeted beverage for 1 year, using methods that build upon previous successful work. Careful attention will be given to assuring treatment fidelity, equivalence of treatment intensity, and avoidance of experimental confounders. The primary study endpoint will be the ratio of serum triglyceride to HDL-cholesterol concentrations. Secondary endpoints will include changes in other cardiovascular disease risk factors, body weight, dietary quality, and taste preferences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar-Sweetened Beverages | Active Comparator | Provision of beverages: Sugar-sweetened beverages |
|
| Artificially-sweetened Beverages | Experimental | Provision of beverages: Artificially-sweetened beverages |
|
| Unsweetened Beverages | Experimental | Provision of beverages: Unsweetened beverages |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provision of beverages | Behavioral | Home delivery of specified beverage type |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) | 12 Month |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C | LDL-C | 12 Month |
| hsCRP | hsCRP | 12 Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16510646 | Background | Ebbeling CB, Feldman HA, Osganian SK, Chomitz VR, Ellenbogen SJ, Ludwig DS. Effects of decreasing sugar-sweetened beverage consumption on body weight in adolescents: a randomized, controlled pilot study. Pediatrics. 2006 Mar;117(3):673-80. doi: 10.1542/peds.2005-0983. | |
| 22998339 | Background | Ebbeling CB, Feldman HA, Chomitz VR, Antonelli TA, Gortmaker SL, Osganian SK, Ludwig DS. A randomized trial of sugar-sweetened beverages and adolescent body weight. N Engl J Med. 2012 Oct 11;367(15):1407-16. doi: 10.1056/NEJMoa1203388. Epub 2012 Sep 21. |
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3607 participants were initially telephone screened; 1462 were eligible after telephone screening; 407 were eligible after an Informational Visit; 222 provided informed consent; 19 withdrew or were found ineligible prior to completing baseline assessments. 203 participants completed baseline assessments and were randomized.
Subjects were recruited from the Boston metro area via multiple recruitment methods (i.e., print media, social media) from February 2011 through October 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugar-Sweetened Beverages | Provision of beverages: Sugar-sweetened beverages Provision of beverages: Home delivery of specified beverage type |
| FG001 | Artificially-sweetened Beverages | Provision of beverages: Artificially-sweetened beverages Provision of beverages: Home delivery of specified beverage type |
| FG002 | Unsweetened Beverages | Provision of beverages: Unsweetened beverages Provision of beverages: Home delivery of specified beverage type |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugar-Sweetened Beverages | Sugar-sweetened beverages Provision of beverages: Home delivery of specified beverage type |
| BG001 | Artificially-Sweetened Beverages | Artificially-sweetened beverages Provision of beverages: Home delivery of specified beverage type |
| 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 | Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) | Posted | Median | Inter-Quartile Range | ratio of Triglycerides-to-HDL | 12 Month |
|
1 year
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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 | Group 1 | Sugar-sweetened beverages Provision of beverages: Home delivery of specified beverage type |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Body Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hospitalized for pain management of a severely pulled muscle in chest. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Ludwig | Boston Children's Hospital | 617-355-4878 | david.ludwig@childrens.harvard.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Fibrinogen |
Fibrinogen |
| 12 Month |
| Uric Acid | Uric Acid | 12 Month |
| ALT | ALT | 12 Month |
| Systolic Blood Pressure | Systolic Blood Pressure | 12 Month |
| Diastolic Blood Pressure | Diastolic Blood Pressure | 12 Month |
| Body Weight | Body Weight | 12 Month |
| Diet Quality: Sugar-Sweetened Beverage Consumption | Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day | 12 Month |
| Preference for Sweet Taste | We evaluated preference for sweet taste using ten solutions ranging in sucrose concentration (%m/v) from 0% (sample 1) to 18% (sample 10). After tasting each solution, participant reported the sample number corresponding to his or her overall favorite. | 12 Month |
| 32696704 | Derived | Ebbeling CB, Feldman HA, Steltz SK, Quinn NL, Robinson LM, Ludwig DS. Effects of Sugar-Sweetened, Artificially Sweetened, and Unsweetened Beverages on Cardiometabolic Risk Factors, Body Composition, and Sweet Taste Preference: A Randomized Controlled Trial. J Am Heart Assoc. 2020 Aug 4;9(15):e015668. doi: 10.1161/JAHA.119.015668. Epub 2020 Jul 22. |
| BG002 | Unsweetened Beverages | Unsweetened beverages Provision of beverages: Home delivery of specified beverage type |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) | Mean | Inter-Quartile Range | ratio of Triglycerides-to-HDL |
|
| LDL-C | Mean | Standard Deviation | mg/dL |
|
| hsCRP | Median | Inter-Quartile Range | mg/L |
|
| Fibrinogen | Mean | Standard Deviation | mg/dL |
|
| Uric Acid | Mean | Standard Deviation | mg/dL |
|
| ALT | Median | Inter-Quartile Range | U/L |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Diet Quality: Sugar-Sweetened Beverage Consumption | Mean | Standard Deviation | Servings per day |
|
| Preference for sweet taste | We evaluated preference for sweet taste using ten solutions ranging in sucrose concentration (%m/v) from 0% (sample 1) to 18% (sample 10). After tasting each solution, participant reported the sample number corresponding to his or her overall favorite. | Median | Inter-Quartile Range | Sample number |
|
Provision of beverages: Unsweetened beverages
Provision of beverages: Home delivery of specified beverage type
|
|
| Secondary | LDL-C | LDL-C | Posted | Mean | Standard Deviation | mg/dL | 12 Month |
|
|
|
| Secondary | hsCRP | hsCRP | Posted | Median | Inter-Quartile Range | mg/L | 12 Month |
|
|
|
| Secondary | Fibrinogen | Fibrinogen | Posted | Mean | Standard Deviation | mg/dL | 12 Month |
|
|
|
| Secondary | Uric Acid | Uric Acid | Posted | Mean | Standard Deviation | mg/dL | 12 Month |
|
|
|
| Secondary | ALT | ALT | Posted | Median | Inter-Quartile Range | U/L | 12 Month |
|
|
|
| Secondary | Systolic Blood Pressure | Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | 12 Month |
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | 12 Month |
|
|
|
| Secondary | Body Weight | Body Weight | Data missing for 1 subject in ASB group. | Posted | Mean | Standard Deviation | kg | 12 Month |
|
|
|
| Secondary | Diet Quality: Sugar-Sweetened Beverage Consumption | Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day | Data missing for 1 subject in USB group. | Posted | Mean | Standard Deviation | Servings per day | 12 Month |
|
|
|
| Secondary | Preference for Sweet Taste | We evaluated preference for sweet taste using ten solutions ranging in sucrose concentration (%m/v) from 0% (sample 1) to 18% (sample 10). After tasting each solution, participant reported the sample number corresponding to his or her overall favorite. | Data missing for 1 subject in SSB group. | Posted | Median | Inter-Quartile Range | Sample number | 12 Month |
|
|
|
| 2 |
| 67 |
| 0 |
| 67 |
| EG001 | Group 2 | Artificially-sweetened beverages Provision of beverages: Home delivery of specified beverage type | 1 | 67 | 0 | 67 |
| EG002 | Group 3 | Unsweetened beverages Provision of beverages: Home delivery of specified beverage type | 0 | 69 | 0 | 69 |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hospitalized for asthma |
|
| Headaches and mood swings due to toothache | Nervous system disorders | Systematic Assessment | Severe headaches and mood swings due to toothache |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |