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NCT02675101 · ClinicalTrials.gov registry record · NA
Nuts and Olestra for Persistent Organic Pollutant Reduction (NO-POPs) Trial
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT02675101 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 45 participants.
The verdict
NCT02675101, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study Summary
Persistent organic pollutants (POPs) are mostly fat-soluble halogenated chemicals with very long half-lives. POPs are endocrine disruptors, associated with increased risk for diabetes, alterations in thyroid function, and cardiovascular disease in humans. POPs concentrations increase with age because of their persistence, bioaccumulation and poor excretion. The almost ubiquitous presence of endocrine disrupting POPs in US adults is a substantial public health concern, particularly because there is no established treatment to reduce body concentrations of POPs. Most POPs are excreted in bile due to their lipophilic nature. However, a substantial amount is reabsorbed in the small intestine and returns to the blood stream (entero-hepatic circulation). The objective of this pilot study is to conduct a 6-month randomized controlled trial of Nuts and Olestra to enhance the excretion of POPs among 45 healthy adults aged 45 to 70 years with BMIs between 18-30 kg/m2. This study has 3 treatment arms: A) Whole nuts with high fat content (almonds and walnuts; 110g total/day, n=15), B) Olestra: Fat Free PringlesTM potato chips (≈29 crisps, 18g of Olestra/day; n=15), C) Vegetable oil: Original PringlesTM potato chips (≈29 crisps, 17.4g of oil/day; n=15). The investigators aim to measure change in concentrations of 24 POPs in feces after 4 days of treatment and in blood at 6 months.
Interventions
- OTHER Whole Nuts
- OTHER Olestra: Fat Free Pringles
- OTHER Vegetable Oil: Original Pringles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2016-03 |
| Est. Completion | 2019-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02675101
The ClinicalTrials.gov registry entry for NCT02675101 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Whole Nuts is the first listed.
NCT02675101 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02675101 about?
NCT02675101 is a clinical study titled "Nuts and Olestra for Persistent Organic Pollutant Reduction (NO-POPs) Trial". Persistent organic pollutants (POPs) are mostly fat-soluble halogenated chemicals with very long half-lives. POPs are endocrine disruptors, associated with increased risk for diabetes, alterations in thyroid function, and cardiovascular disease in humans. POPs concentrations increase with age becaus...
What is the current status of trial NCT02675101?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2016-03. Estimated completion is 2019-04-01.
What interventions are being tested in trial NCT02675101?
The interventions under investigation include: Whole Nuts (OTHER), Olestra: Fat Free Pringles (OTHER), Vegetable Oil: Original Pringles (OTHER).
Who is sponsoring clinical trial NCT02675101?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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