Beverages and Societal Health

Boston Children's Hospital203 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

203

Conditions

Cardiovascular Disease, Obesity

Interventions

Provision of beveragesBEHAVIORAL

Home delivery of specified beverage type

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital Boston

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)

Time frame: 12 Month

Secondary Outcomes

LDL-C

Time frame: 12 Month

hsCRP

Time frame: 12 Month

Fibrinogen

Time frame: 12 Month

Uric Acid

Time frame: 12 Month

ALT

Time frame: 12 Month

Systolic Blood Pressure

Time frame: 12 Month

Diastolic Blood Pressure

Time frame: 12 Month

Body Weight

Time frame: 12 Month

Diet Quality: Sugar-Sweetened Beverage Consumption

Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day

Time frame: 12 Month

Preference for Sweet Taste

Data from ClinicalTrials.gov

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