NCT01295671

Beverages and Societal Health

Sugar Sweetened Beverages And Cardiovascular Disease Risk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Disease, Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Provision of beverages	Home delivery of specified beverage type

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2011-02-14
• Last updated: 2018-03-27
• Results posted: 2018-03-27

Locations

1 site across 1 country: United States