Beverages and Societal Health

Cardiovascular Disease, Obesity Clinical Trial

— BASH III  

Official title:

Sugar Sweetened Beverages And Cardiovascular Disease Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295671
• Other study ID #: 10-06-0242
• Status: Completed
• Phase: N/A
• First received: February 11, 2011
• Last updated: February 27, 2018
• Start date: February 2011
• Est. completion date: November 2015

Study information

• Verified date: February 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease, Obesity
• Cardiovascular Diseases

Intervention

Behavioral:
• Provision of beverages
Home delivery of specified beverage type

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)		12 Month
Secondary	LDL-C	LDL-C	12 Month
Secondary	hsCRP	hsCRP	12 Month
Secondary	Fibrinogen	Fibrinogen	12 Month
Secondary	Uric Acid	Uric Acid	12 Month
Secondary	ALT	ALT	12 Month
Secondary	Systolic Blood Pressure	Systolic Blood Pressure	12 Month
Secondary	Diastolic Blood Pressure	Diastolic Blood Pressure	12 Month
Secondary	Body Weight	Body Weight	12 Month
Secondary	Diet Quality: Sugar-Sweetened Beverage Consumption	Diet Quality: Sugar-Sweetened Beverage Consumption - 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.	12 Month