Nuts and Olestra for Persistent Organic Pollutant Reduction (NO-POPs) Trial (NCT02675101) | Clinical Trial Compass
CompletedNot Applicable
Nuts and Olestra for Persistent Organic Pollutant Reduction (NO-POPs) Trial
United States45 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range
45 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in blood levels of persistent organic pollutants (POPS) in response to being assigned an olestra -enriched diet (fat-free Pringles) compared to a diet enriched with vegetable oil (original Pringles) over a 6-month period
Timeframe: 6 months
2
Change in fecal excretion of persistent organic pollutants (POPS) in response to being assigned an olestra -enriched diet (fat-free Pringles) compared to a diet enriched with vegetable oil (original Pringles) over a 6-month period