At a glance
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Nuts and Olestra for Persistent Organic Pollutant Reduction (NO-POPs) Trial: A Pilot Investigation
In Brief
A clinical study evaluating Whole Nuts, Olestra: Fat Free Pringles, and 1 other intervention for Persistent Organic Pollutants and 2 related conditions. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
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.