Beverages and Societal Health (BASH III)

Sugar Sweetened Beverages And Cardiovascular Disease Risk

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease, Obesity
• Intervention / Treatment: Behavioral: Provision of beverages

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.

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

General Publications

• 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. doi: 10.1542/peds.2005-0983.
• 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.
• Ebbeling CB, Feldman HA, Steltz SK, Quinn NL, Robinson LM, Ludwig DS. Effects of Sugar-Sweetened, Artificially Sweetened, and Unsweetened Beverages on Cardiometabolic Risk Factors, Body Composition, and Sweet Taste Preference: A Randomized Controlled Trial. J Am Heart Assoc. 2020 Aug 4;9(15):e015668. doi: 10.1161/JAHA.119.015668. Epub 2020 Jul 22.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: February 11, 2011
• First Submitted That Met QC Criteria: February 11, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 10-06-0242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No