Endocrine Disrupting Chemicals Clinical Trial
Official title:
Nuts and Olestra for Persistent Organic Pollutant Reduction (NO-POPs) Trial: A Pilot Investigation
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:
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).
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