View Clinical Trial (Medical Research Study)
Sugar Sweetened Beverages And Cardiovascular Disease Risk
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02115 |
| Conditions: |
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Cardiovascular Disease, Obesity |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01295671 |
| Primary Contact: |
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Cara B Ebbeling, PhD
Phone: 617 355-2379
Email: cara.ebbeling@childrens.harvard.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02115
United States
Cara B Ebbeling, PhD
Phone: 617-355-4878
Email: cara.ebbeling@childrens.harvard.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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