Soda and Milk Study
NCT02094768 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2017-11-06
Summary
Much attention has been directed at the unhealthy effects of sugar-sweetened beverages (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In adults, SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides compared to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages. Replacement of soda with milk had the added benefit of also reducing systolic blood pressure. While several studies have investigated the effects of SSBs on weight gain in children, no published studies have investigated their effects on lipid and lipoprotein risk factors under isocaloric conditions in metabolically at-risk adolescents, who are among the greatest consumers of SSBs. The main objective of this study is to test whether isocaloric replacement of soda with reduced fat milk will significantly improve atherogenic dyslipidemia, blood pressure, insulin sensitivity, and liver function in overweight and obese adolescents who are habitual soda consumers. The investigators will test this in a 8 week randomized two period crossover trial in 30 overweight and obese adolescent males who are self-reported habitual consumers of SSBs. Participants will consume energy equivalent amounts of SSB (24oz soda containing high fructose corn syrup per day), and reduced fat milk (2% milk fat) for 3 weeks each, in random order, separated by a 2-week washout. Anthropometrics, blood pressure, and blood samples will be collected at screen and at the end of each intervention period. Plasma measurements will include LDL peak particle diameter; lipoprotein subclass concentrations; triglycerides; total, LDL, and HDL-cholesterol; apolipoproteins; glucose, insulin, and insulin resistance; high sensitivity C-reactive protein; uric acid; and liver enzymes.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Reduced Fat Milk
Subjects will be provided with and instructed to consume the equivalent of 20oz. reduced fat milk per day for 3 weeks
- DIETARY_SUPPLEMENT
-
Sugar Sweetened Soda
Subjects will be provided with and instructed to consume 2 cans (24oz) of sugar sweetened soda per day for 3 weeks
Sponsors & Collaborators
-
Almond Board of California
collaborator OTHER -
UCSF Benioff Children's Hospital Oakland
lead OTHER
Principal Investigators
-
Ronald M Krauss, MD · UCSF Benioff Children's Hospital Oakland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 13 Years
- Max Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2016-09-30
- Completion
- 2017-05-31
Countries
- United States
Study Locations
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