Nuts and Olestra for Persistent Organic Pollutant Reduction (NO-POPs) Trial: A Pilot Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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:
- Assess the effectiveness of recruitment strategies, acceptance and compliance of the treatment arms, and establishing the feasibility of conducting a larger trial.
- 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).
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Nut allergies
- •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
研究组 & 干预措施
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.
干预措施: Whole Nuts (Other)
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.
干预措施: Olestra: Fat Free Pringles (Other)
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.
干预措施: Vegetable Oil: Original Pringles (Other)
结局指标
主要结局
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
时间窗: 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
时间窗: 6 months
次要结局
- 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)
研究者
Jose R Suarez
MPH, MD, PhD
University of California, San Diego