Beverages and Societal Health

NCT ID: NCT01295671

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2015-11-30

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.

Conditions

Cardiovascular Disease, Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sugar-Sweetened Beverages

Provision of beverages: Sugar-sweetened beverages

Group Type: ACTIVE_COMPARATOR

Provision of beverages

Intervention Type: BEHAVIORAL

Home delivery of specified beverage type

Artificially-sweetened Beverages

Provision of beverages: Artificially-sweetened beverages

Group Type: EXPERIMENTAL

Provision of beverages

Intervention Type: BEHAVIORAL

Home delivery of specified beverage type

Unsweetened Beverages

Provision of beverages: Unsweetened beverages

Group Type: EXPERIMENTAL

Provision of beverages

Intervention Type: BEHAVIORAL

Home delivery of specified beverage type

Interventions

Provision of beverages

Home delivery of specified beverage type

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

David S. Ludwig, MD, PhD

Director, Obesity Prevention Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital Boston

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16510646 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22998339 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32696704 (View on PubMed)

Other Identifiers

10-06-0242

Identifier Type: -

Identifier Source: org_study_id