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

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT02675101
Collaborator
San Diego State University (Other)
45
Enrollment
1
Location
3
Arms
37
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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),

  1. 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.
Condition or Disease Intervention/Treatment Phase
  • Other: Whole Nuts
  • Other: Olestra: Fat Free Pringles
  • Other: Vegetable Oil: Original Pringles
 N/A

Detailed Description

Persistent organic pollutants (POPs) are mostly fat-soluble halogenated chemicals with very long half-lives. POPs are endocrine disruptors, and have been associated with increased risk for diabetes, alterations in thyroid function, hypertension, dyslipidemia and neurobehavioral alterations in studies of children, and adults including the elderly. Some of the most prevalent POPs include organochlorine pesticides, polychlorinated biphenyls (PCBs) and polybrominated diphenyl ethers (PBDEs).

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Nuts and Olestra for Persistent Organic Pollutant Reduction (NO-POPs) Trial: A Pilot Investigation
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Other: 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.
Experimental: 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.

Other: 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.
Placebo Comparator: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  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 [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 [6 months]

Secondary Outcome Measures

  1. 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]

  2. 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 Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCSD Moores Cancer Center La Jolla California United States 92093

Sponsors and Collaborators

  • University of California, San Diego
  • San Diego State University

Investigators

  • Principal Investigator: Jose R Suarez, MPH, MD, PhD, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jose R Suarez, MPH, MD, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02675101
Other Study ID Numbers:
  • 160096
First Posted:
Feb 5, 2016
Last Update Posted:
Jul 5, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Sucrose polyester

Study Results

No Results Posted as of Jul 5, 2019