Nuts and Olestra for Persistent Organic Pollutant Reduction (NO-POPs) Trial
NCT ID: NCT02675101
Last Updated: 2019-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2016-03-31
2019-04-01
Brief Summary
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Detailed Description
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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). Two small clinical trials found that bile acid sequestrants (cholestyramine, cholestimide) enhanced the fecal excretion of organochlorines after 2-3 days of treatment and significantly lowered their blood concentrations at 6 months. One pilot trial reported decreases in blood PCB concentrations in adults after a 1 year treatment with fat-free potato crisps made with olestra, a non-absorbable synthetic fat, versus standard potato crisps. POPs were thought to bind to olestra and be excreted in the feces. Replication of this finding is needed. Nuts, could yield similar effects. Nuts are foods with high-fat content which are incompletely absorbed in the intestine (21-24% of calorie not absorbed).
As people age, the body burdens of POPs increase. 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. There is potential for dietary interventions to have an important role in the reduction of POPs at a population level due to their and low cost and wide use.
The investigators aim to measure 24 POPs (9 OC pesticides, 10 PCBs, 5 PBDEs) in blood (all participants) and in stool samples (only in a subset of 10 participants per treatment arm) before and during the treatment period. The specific aims of this pilot study are to:
1. Assess the effectiveness of recruitment strategies, acceptance and compliance of the treatment arms, and establishing the feasibility of conducting a larger trial.
2. Conduct preliminary testing of the hypotheses: Consumption of olestra (fat free Pringles): A) increases the fecal content (excretion) of POPs, and B) decreases blood levels of POPs, compared to the control arm (standard crisps).
3. Conduct preliminary testing of the hypotheses: Consumption of nuts: A) increases the fecal content (excretion) of POPs, and B) decreases blood levels of POPs, compared to the control arm (standard crisps).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Whole nuts
Participants will be advised on maintaining an iso-caloric diet by a Registered Dietitian. During the 6-month intervention, study subjects will consume a combination of whole almonds and walnut pieces, a total of 110 g per day. Participants will pick up supplies and be weighed 1-2 times per month for six months. Participants will also maintain a diary of their intake using an automated system. Walnuts and almonds will be provided to participants for the duration of the study.
Whole Nuts
Participants will be advised on maintaining an iso-caloric diet. Aside consuming nuts, the remaining composition of the prescribed diet will be based on individual preferences. During the 6-month intervention, study subjects will meet with study staff every 2-3 weeks to weigh in, pick up food supplies and complete a questionnaire on compliance. All participants will have contact with the project coordinator/study dietitian a minimum of every 1-2 weeks either in-person, telephone, email and text message contacts for support, behavioral guidance and strategies. Both walnuts and almonds will be provided to participants in the whole nut study arm.
Olestra: Fat Free Pringles
Participants will be advised on maintaining an iso-caloric diet by a Registered Dietitian. During the 6-month intervention, study subjects will consume 29 potato crisps per day, which is approximately 18 g olestra/day. Participants will pick up supplies and be weighed 1-2 times per month for six months. Participants will also maintain a diary of their intake using an automated system. Fat free Pringles will be provided to participants for the duration of the study.
Olestra: Fat Free Pringles
Participants will be advised on maintaining an iso-caloric diet. Aside consuming fat free potato crisps, the remaining composition of the prescribed diet will be based on individual preferences. During the 6-month intervention, study subjects will meet with study staff every 2-3 weeks to weigh in, pick up food supplies and complete a questionnaire on compliance. All participants will have contact with the project coordinator/study dietitian a minimum of every 1-2 weeks either in-person, telephone, email and text message contacts for support, behavioral guidance and strategies. Fat Free Pringles will be provided to participants in the olestra study arm.
Vegetable Oil: Original Pringles
Participants will be advised on maintaining an iso-caloric diet by a Registered Dietitian. During the 6-month intervention, study subjects will consume 29 potato crisps per day, which is approximately 17.4 g oil/day. Participants will pick up supplies and be weighed 1-2 times per month for six months. Participants will also maintain a diary of their intake using an automated system. Original Pringles will be provided to participants for the duration of the study.
Vegetable Oil: Original Pringles
Participants will be advised on maintaining an iso-caloric diet. Aside consuming potato crisps, the remaining composition of the prescribed diet will be based on individual preferences. During the 6-month intervention, study subjects will meet with study staff every 2-3 weeks to weigh in, pick up food supplies and complete a questionnaire on compliance. All participants will have contact with the project coordinator/study dietitian a minimum of every 1-2 weeks either in-person, telephone, email and text message contacts for support, behavioral guidance and strategies. Original Pringles will be provided to participants in the vegetable oil study arm.
Interventions
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Whole Nuts
Participants will be advised on maintaining an iso-caloric diet. Aside consuming nuts, the remaining composition of the prescribed diet will be based on individual preferences. During the 6-month intervention, study subjects will meet with study staff every 2-3 weeks to weigh in, pick up food supplies and complete a questionnaire on compliance. All participants will have contact with the project coordinator/study dietitian a minimum of every 1-2 weeks either in-person, telephone, email and text message contacts for support, behavioral guidance and strategies. Both walnuts and almonds will be provided to participants in the whole nut study arm.
Olestra: Fat Free Pringles
Participants will be advised on maintaining an iso-caloric diet. Aside consuming fat free potato crisps, the remaining composition of the prescribed diet will be based on individual preferences. During the 6-month intervention, study subjects will meet with study staff every 2-3 weeks to weigh in, pick up food supplies and complete a questionnaire on compliance. All participants will have contact with the project coordinator/study dietitian a minimum of every 1-2 weeks either in-person, telephone, email and text message contacts for support, behavioral guidance and strategies. Fat Free Pringles will be provided to participants in the olestra study arm.
Vegetable Oil: Original Pringles
Participants will be advised on maintaining an iso-caloric diet. Aside consuming potato crisps, the remaining composition of the prescribed diet will be based on individual preferences. During the 6-month intervention, study subjects will meet with study staff every 2-3 weeks to weigh in, pick up food supplies and complete a questionnaire on compliance. All participants will have contact with the project coordinator/study dietitian a minimum of every 1-2 weeks either in-person, telephone, email and text message contacts for support, behavioral guidance and strategies. Original Pringles will be provided to participants in the vegetable oil study arm.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
70 Years
ALL
Yes
Sponsors
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San Diego State University
OTHER
University of California, San Diego
OTHER
Responsible Party
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Jose R Suarez
MPH, MD, PhD
Principal Investigators
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Jose R Suarez, MPH, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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UCSD Moores Cancer Center
La Jolla, California, United States
Countries
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References
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Other Identifiers
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160096
Identifier Type: -
Identifier Source: org_study_id
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