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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
Last Update Posted : February 9, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David S. Ludwig, MD, PhD, Children's Hospital Boston

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.

Condition or disease Intervention/treatment
Cardiovascular Disease, Obesity 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  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sugar Sweetened Beverages And Cardiovascular Disease Risk
Study Start Date : February 2011
Primary Completion Date : November 2015
Study Completion Date : November 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Ratio of serum triglyceride to HDL-cholesterol concentration (TG:HDLC) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. CVD Risk Factors [ Time Frame: 12 months ]
    • 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

  2. Body Weight and Composition [ Time Frame: 12 months ]
    • Body weight
    • Body fat percentage (DXA)
    • Waist circumference

  3. Dietary Quality [ Time Frame: 12 months ]
    • Vegetables
    • Fruits
    • Legumes
    • Dietary fiber
    • Selected micronutrients

  4. Taste Preference [ Time Frame: 12 months ]
    • Sweetness rating (sensory)
    • Pleasure rating (hedonic)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01295671

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
National Heart, Lung, and Blood Institute (NHLBI)