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Beverages and Societal Health (BASH III)

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David S. Ludwig, MD, PhD, Children's Hospital Boston Identifier:
First received: February 11, 2011
Last updated: February 8, 2016
Last verified: February 2016
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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sugar Sweetened Beverages And Cardiovascular Disease Risk

Further study details as provided by David S. Ludwig, MD, PhD, Children's Hospital Boston:

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

Secondary Outcome Measures:
  • 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

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

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

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

Enrollment: 203
Study Start Date: February 2011
Study Completion Date: November 2015
Primary Completion Date: November 2015 (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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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)
  More Information

Responsible Party: David S. Ludwig, MD, PhD, Director, Obesity Prevention Center, Children's Hospital Boston Identifier: NCT01295671     History of Changes
Other Study ID Numbers: 10-06-0242
Study First Received: February 11, 2011
Last Updated: February 8, 2016

Additional relevant MeSH terms:
Cardiovascular Diseases processed this record on September 21, 2017