N/A
N=203
Beverages and Societal Health
Cardiovascular Disease, Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01295671 ↗Enrolled (actual)
203
Serious AEs
1.5%
Results posted
Mar 2018
Primary outcome: Primary: Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) — 1.46; 1.19; 1.45 ratio of Triglycerides-to-HDL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Provision of beverages (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) |
1.46; 1.19; 1.45 | — |
| SECONDARY LDL-C |
103; 104; 109 | — |
| SECONDARY hsCRP |
0.86; 0.64; 0.85 | — |
| SECONDARY Fibrinogen |
244; 248; 236 | — |
| SECONDARY Uric Acid |
5.2; 5.1; 5.4 | — |
| SECONDARY ALT |
16; 16; 17 | — |
| SECONDARY Systolic Blood Pressure |
109; 107; 106 | — |
| SECONDARY Diastolic Blood Pressure |
68; 67; 67 | — |
| SECONDARY Body Weight |
78.0; 76.8; 78.3 | — |
| SECONDARY Diet Quality: Sugar-Sweetened Beverage Consumption |
2.5; 0.1; 0.2 | — |
| SECONDARY Preference for Sweet Taste |
6; 6; 5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01295671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.