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NCT02094768 · ClinicalTrials.gov registry record · NA
Soda and Milk Study
A NA study, sponsored by UCSF Benioff Children's Hospital Oakland.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT02094768: Completed NA study, sponsored by UCSF Benioff Children's Hospital Oakland.
NCT02094768 is a NA study that has completed, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02094768, a NA study, has completed, sponsored by UCSF Benioff Children's Hospital Oakland.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Reduced Fat Milk
- DIETARY_SUPPLEMENT Sugar Sweetened Soda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-04 |
| Est. Completion | 2017-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02094768
The ClinicalTrials.gov registry entry for NCT02094768 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCSF Benioff Children's Hospital Oakland, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Reduced Fat Milk is the first listed.
NCT02094768 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02094768 about?
NCT02094768 is a clinical study titled "Soda and Milk Study". 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 se...
What is the current status of trial NCT02094768?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2014-04. Estimated completion is 2017-05.
What interventions are being tested in trial NCT02094768?
The interventions under investigation include: Reduced Fat Milk (DIETARY_SUPPLEMENT), Sugar Sweetened Soda (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02094768?
This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.
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