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Beverages and Societal Health (BASH III)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Children's Hospital Boston
Sponsor:
Collaborator:
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

February 11, 2011
January 7, 2013
February 2011
February 2014   (final data collection date for primary outcome measure)
Ratio of serum triglyceride to HDL-cholesterol concentration (TG:HDLC) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01295671 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
  • 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)
Not Provided
Not Provided
 
Beverages and Societal Health
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cardiovascular Disease, Obesity
Behavioral: Provision of beverages
Home delivery of specified beverage type
  • Active Comparator: Group 1
    Sugar-sweetened beverages
    Intervention: Behavioral: Provision of beverages
  • Experimental: Group 2
    Artificially-sweetened beverages
    Intervention: Behavioral: Provision of beverages
  • Experimental: Group 3
    Unsweetened beverages
    Intervention: Behavioral: Provision of beverages
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
July 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact: Cara B Ebbeling, PhD 617 355-2379 cara.ebbeling@childrens.harvard.edu
United States
 
NCT01295671
10-06-0242
No
Children's Hospital Boston
Children's Hospital Boston
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Children's Hospital Boston
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP