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| Name | Class |
|---|---|
| San Diego State University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose R Suarez, MPH, MD, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Moores Cancer Center | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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|
| 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. |
|
| 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. |
|
| 6 months |
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