Nuts and Olestra for Persistent Organic Pollutant Reduction (NO-POPs) Trial

NCT02675101 | Completed

• 1 other identifier: 160096
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Organic Pollutants; Endocrine Disrupting Chemicals; Endocrine Disruptor Effects

Outcome Measures

Primary Outcomes (2)

• 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

  6 months

• 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

  6 months

Secondary Outcomes (2)

• Change in blood levels of persistent organic pollutants (POPS) in response to being assigned a nut-enriched diet compared to a diet enriched with vegetable oil (original Pringles) over a 6-month period

  6 months

• Change in fecal excretion of persistent organic pollutants (POPS) in response to being assigned a nut-enriched diet compared to a diet enriched with vegetable oil (original Pringles) over a 6-month period

  6 months

Other Outcomes (1)

• Change in blood lipids in response to being assigned an olestra -enriched diet (fat-free Pringles), a vegetable oil-enriched diet (original Pringles) or a nut-enriched diet over a 6-month period, as an exploratory aim.

  6 months

Study Arms (3)

Whole nuts

ACTIVE COMPARATOR

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.

Other: Whole Nuts

Olestra: Fat Free Pringles

EXPERIMENTAL

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.

Other: Olestra: Fat Free Pringles

Vegetable Oil: Original Pringles

PLACEBO COMPARATOR

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.

Other: Vegetable Oil: Original Pringles

Interventions

Whole Nuts OTHER

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.

Whole nuts

Olestra: Fat Free Pringles OTHER

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.

Olestra: Fat Free Pringles

Vegetable Oil: Original Pringles OTHER

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.

Vegetable Oil: Original Pringles

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, San Diego: lead
• San Diego State University: collaborator

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

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Study Officials

• Jose R Suarez, MPH, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MPH, MD, PhD

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 5, 2016
• Study Start: March 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)