Beverages and Societal Health (BASH III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01295671
Recruitment Status : Completed
First Posted : February 14, 2011
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David S. Ludwig, MD, PhD, Boston Children’s Hospital

February 11, 2011
February 14, 2011
October 19, 2017
March 27, 2018
March 27, 2018
February 2011
November 2015   (Final data collection date for primary outcome measure)
Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) [ Time Frame: 12 Month ]
Same as current
Complete list of historical versions of study NCT01295671 on Archive Site
  • LDL-C [ Time Frame: 12 Month ]
  • hsCRP [ Time Frame: 12 Month ]
  • Fibrinogen [ Time Frame: 12 Month ]
  • Uric Acid [ Time Frame: 12 Month ]
    Uric Acid
  • ALT [ Time Frame: 12 Month ]
  • Systolic Blood Pressure [ Time Frame: 12 Month ]
    Systolic Blood Pressure
  • Diastolic Blood Pressure [ Time Frame: 12 Month ]
    Diastolic Blood Pressure
  • Body Weight [ Time Frame: 12 Month ]
    Body Weight
  • Diet Quality: Sugar-Sweetened Beverage Consumption [ Time Frame: 12 Month ]
    Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day
  • Preference for Sweet Taste [ Time Frame: 12 Month ]
    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.
  • CVD Risk Factors [ Time Frame: 12 Month ]
    • 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 Month ]
    • Body weight
    • Body fat percentage (DXA)
    • Waist circumference
  • Dietary Quality [ Time Frame: 12 Month ]
    • Vegetables
    • Fruits
    • Legumes
    • Dietary fiber
    • Selected micronutrients
  • Taste Preference [ Time Frame: 12 Month ]
    • 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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Cardiovascular Disease, Obesity
Behavioral: Provision of beverages
Home delivery of specified beverage type
  • Active Comparator: Sugar-Sweetened Beverages
    Provision of beverages: Sugar-sweetened beverages
    Intervention: Behavioral: Provision of beverages
  • Experimental: Artificially-sweetened Beverages
    Provision of beverages: Artificially-sweetened beverages
    Intervention: Behavioral: Provision of beverages
  • Experimental: Unsweetened Beverages
    Provision of beverages: Unsweetened beverages
    Intervention: Behavioral: Provision of beverages

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2015
November 2015   (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)
  • 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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: No
David S. Ludwig, MD, PhD, Boston Children’s Hospital
Boston Children’s Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Boston Children’s Hospital
February 2018

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