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Beverages and Societal Health (BASH III)

This study is currently recruiting participants.
Verified January 2013 by Children's Hospital Boston
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01295671
First received: February 11, 2011
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Cardiovascular Disease, Obesity
 Behavioral: Provision of beverages

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sugar Sweetened Beverages And Cardiovascular Disease Risk

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Ratio of serum triglyceride to HDL-cholesterol concentration (TG:HDLC) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CVD Risk Factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • Blood lipids (TG, HDLC, LDLC)
    • Inflammation (high-sensitivity C-reactive protein, hsCRP)
    • Coagulation (PAI-1, Fibrinogen)
    • Blood pressure
    • Uric acid
    • Insulin sensitivity (Homeostasis Model Assessment, HOMA)
    • β-cell function (HOMA)
    • Liver function (ALT)
    • Oxidative stress by urinary F2-isoprostanes

  • Body Weight and Composition [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • Body weight
    • Body fat percentage (DXA)
    • Waist circumference

  • Dietary Quality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • Vegetables
    • Fruits
    • Legumes
    • Dietary fiber
    • Selected micronutrients

  • Taste Preference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • Sweetness rating (sensory)
    • Pleasure rating (hedonic)


Estimated Enrollment: 270
Study Start Date: February 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Sugar-sweetened beverages
 Behavioral: Provision of beverages
Home delivery of specified beverage type
Experimental: Group 2
Artificially-sweetened beverages
 Behavioral: Provision of beverages
Home delivery of specified beverage type
Experimental: Group 3
Unsweetened beverages
 Behavioral: Provision of beverages
Home delivery of specified beverage type

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  • Residing in a dormitory at a college or university
  • 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 ≥100 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295671

Contacts
Contact: Cara B Ebbeling, PhD 617 355-2379 cara.ebbeling@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Cara B Ebbeling, PhD     617-355-4878     cara.ebbeling@childrens.harvard.edu    
Sub-Investigator: Cara B Ebbeling, PhD            
Principal Investigator: David S Ludwig, MD, PhD            
Sub-Investigator: Henry A Feldman, PhD            
Sponsors and Collaborators
Children's Hospital Boston
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Publications:

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01295671     History of Changes
Other Study ID Numbers: 10-06-0242
Study First Received: February 11, 2011
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013