Beverages and Societal Health

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Sugar-Sweetened Beverages	Provision of beverages	Provision of beverages: Sugar-sweetened beverages
Unsweetened Beverages	Provision of beverages	Provision of beverages: Unsweetened beverages
Artificially-sweetened Beverages	Provision of beverages	Provision of beverages: Artificially-sweetened beverages

Primary Outcome Measures

Name	Time	Method
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)	12 Month

Secondary Outcome Measures

Name	Time	Method
Body Weight	12 Month	Body Weight
Uric Acid	12 Month	Uric Acid
Diastolic Blood Pressure	12 Month	Diastolic Blood Pressure
Diet Quality: Sugar-Sweetened Beverage Consumption	12 Month	Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day
Fibrinogen	12 Month	Fibrinogen
ALT	12 Month	ALT
hsCRP	12 Month	hsCRP
LDL-C	12 Month	LDL-C
Systolic Blood Pressure	12 Month	Systolic Blood Pressure
Preference for Sweet Taste	12 Month	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.