Beverages and Societal Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sugar Sweetened Beverages And Cardiovascular Disease Risk

Conditions
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Cardiovascular Disease, Obesity

Intervention / Treatment
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* Behavioral: Provision of beverages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 40 years Consumption of at least 12 fluid ounces of sugar-sweetened beverage per day Willingness to consume types of beverages consistent with group assignment Body mass index (BMI) ranging from 18.5 - 40 kg/m2, and body weight ≤275 pounds Access to a working telephone or cell phone Exclusion Criteria: Intention to move away from the greater Boston area during the projected period of study enrollment (i.e., 1 year post-randomization) Plans to be away from home for 5 weeks or longer during the study period (e.g., moving away from the greater Boston area during the summer) Physician diagnosis of a major medical illness, eating disorder, or phenylketonuria (PKU) Chronic use of any medication that may affect one or more study endpoints Impaired fasting glucose (IFG, fasting blood glucose ≥110 mg/dL) Current moderate or heavy smoker (>10 cigarettes per day) Another member of the family (i.e., first degree relative) or household participating in the study If female, Pregnant in the past 12 months or planning to become pregnant during the study period Lactating in the preceding 3 months Change in birth control medication in previous 3 months or plans to change during the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sugar-Sweetened Beverages<br>Provision of beverages: Sugar-sweetened beverages | Behavioral: Provision of beverages<br>* Home delivery of specified beverage type<br>|
| Experimental: Artificially-sweetened Beverages<br>Provision of beverages: Artificially-sweetened beverages | Behavioral: Provision of beverages<br>* Home delivery of specified beverage type<br>|
| Experimental: Unsweetened Beverages<br>Provision of beverages: Unsweetened beverages | Behavioral: Provision of beverages<br>* Home delivery of specified beverage type<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) |  | 12 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C | LDL-C | 12 Month | 
| hsCRP | hsCRP | 12 Month | 
| 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 |