Nuts and Olestra for Persistent Organic Pollutant Reduction (NO-POPs) Trial
Completed · Not applicable
Conditions studied: Persistent Organic Pollutants, Endocrine Disrupting Chemicals, Endocrine Disruptor Effects
In brief
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.
Key facts
- Study ID
- NCT02675101
- Run by
- University of California, San Diego
- People needed
- 45
- Starts
- 2016-03-01
- Expected to finish
- 2019-04-01
- Last updated by the study team
- 2019-07-05
Who can join
Age: 45 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Reside in the San Diego area
- BMI ≥18.0 kg/m2 and ≤30 kg/m2
- Non-smoker
- Willing and able to participate in clinic visits, bi-monthly supply pick-up, telephone and Internet communications at specified intervals
- Able to provide data through questionnaires and by telephone
- Willing to maintain contact with the investigators for 6 months
- Willing to allow blood collections
- Willing to provide stool samples
- No known allergy to tree nuts
- No digestive issues with olestra, chips, or nuts
You may not qualify if…
- Nut allergies
- Smoker
- Diabetes, kidney disease or liver disease
- Concurrent acute or chronic gastro-intestinal conditions (e.g. inflammatory bowel disease, irritable bowel syndrome, concurrent diarrhea from any cause)
- Familial hypercholesterolemia
- Clotting problems or use of Coumadin,
- Inability to participate in physical activity because of severe disability
- History or presence of a co-morbid diseases for which diet modification may be contraindicated
- Self-reported pregnancy or breastfeeding or planning a pregnancy within the next year
- Currently actively involved in another diet intervention study or a weight loss program
- A history or presence of a significant psychiatric disorder or any other condition that, in the investigator's judgement, would interfere with participation in the trial
Where it is running
- UCSD Moores Cancer Center — La Jolla, California, United States
Full record on ClinicalTrials.gov
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