Overweight, Obesity and Other Hyperalimentation Clinical Trial
Official title:
Taking Action to Thrive - A Healthy Lifestyle Intervention Pilot Study
There have been some preliminary studies, primarily in animals, that suggest that exposure to
some of the chemicals in our everyday environment, such as the chemicals found in plastics,
may cause weight gain. It is not clear whether this also happens in humans, or whether
decreasing exposure to these chemicals can improve success with weight loss when people adopt
healthy lifestyle changes.
The THRIVE Study is a 4-week group healthy lifestyle education program that is designed to
determine whether:
- changes in dietary habits and the types of personal care products used can decrease a
person's exposure to chemicals in our environment that have been suggested to cause
weight gain
- whether any measurable changes in body composition (fat tissue vs. lean tissue) can be
seen as a result of participating in the healthy lifestyle program.
Emerging evidence from in vitro and animal models suggests that exposure to endocrine
disrupting chemicals (EDC), or industrial chemicals that alter hormonal action, may
contribute to the development of obesity. Phthalates, a class of industrial chemicals
commonly found in personal care products and food packaging, warrant study since they are
widely detected in the general US population, including reproductive aged-women, and
exposures during adulthood are associated with an increased risk of obesity. However, the
majority of the evidence supporting this hypothesis to date has come from cross-sectional
rather than prospective, longitudinal data. Thus, a causal relationship between EDC exposure
and the development of obesity has not been conclusively established.
Currently, 60.3% (95% CI: 54.2-66.0) of younger adult Americans (aged 20 - 39) are thought to
be overweight or obese (BMI ≥25), which increases the risk of chronic diseases such as
diabetes, cardiovascular disease and cancer. While excess calorie consumption and lack of
physical activity are primary contributors to overweight and obesity, factors other than diet
and physical activity may also contribute to alterations in energy balance over time. The
general public is becoming increasingly concerned about the potential health risks associated
with EDC exposures, including effects on body composition.
The THRIVE Study is designed to evaluate the effect of many different EDCs on body
composition changes. The study will focus initially on exposures to the phthalate class of
EDCs, but data will be collected in a way that will allow investigators to evaluate the
effect of many different EDCs on body composition changes.
Phthalates are a class of high-production-volume industrial chemicals that are ubiquitously
used in commerce. Most phthalates, such as DEHP, are used as plasticizers to impart
flexibility in polyvinyl chloride (PVC) materials such as food packaging, flooring, and
medical devices. In recent years, other phthalates, including diisononyl phthalate (DiNP),
have been replacing DEHP in these applications due, in part, to legislation limiting the use
of DEHP in certain applications such as children's toys. Phthalates can leach, migrate, or
off-gas from products over time and enter the human body through the air we breathe, the food
we eat, and the personal care products that we use on our bodies. Consequently, human
exposure to phthalates is widespread.
Phthalates enter foods through contact with plastics (e.g. tubing, conveyor belts or plastic
gloves made with PVC plastics) or recycled paper/cardboard food containers. Phthalates are
more likely to leach into liquids and non-polar solvents such as fats and oils, and thus are
most commonly found in foods high in animal fats such as dairy products and meat.
Low-molecular weight phthalates, such as DEP, di-n-butyl phthalate (DnBP) and DiBP, are
commonly found in fragranced personal care products such as perfumes, deodorants, soaps,
shampoos, and other hair products (e.g. hair sprays, gels, mousses). They can also be found
in time release medications and supplements. Intervention studies suggest that addressing
sources of exposure can lower human exposure to phthalates. In a study of 20 individuals, a
3-day dietary intervention of "fresh foods" (no canned food or foods wrapped in plastic)
resulted in an average reduction in DEHP metabolites of 53-56%. Similarly, a study of 100
Latina girls found that a 3-day intervention with phthalate free personal care products
resulted in a 27.4% reduction in DEP metabolite (mono-ethyl phthalate) levels.
If phthalate exposures are ultimately found to be associated with body composition changes in
young adults, it could be possible to decrease the risk of these body composition changes by
modifying food selection, preparation and storage techniques, and changing use of personal
care products in addition to traditional diet and physical activity interventions. This, in
turn, could have significant impacts on obesity and chronic disease risk in the US.
While a few studies have indicated that dietary modification and changes in personal care
products use can individually lower urinary phthalate levels, this study will be the first to
combine both a dietary and personal care product intervention. In a study of 20 individuals,
a 3-day dietary intervention of "fresh foods" (no canned food or foods wrapped in plastic)
resulted in an average reduction in DEHP metabolites of 53-56%. Similarly, a study of 100
Latina girls found that a 3-day intervention with phthalate free personal care products
resulted in a 27.4% reduction in DEP metabolite (mono-ethyl phthalate) levels. The hypothesis
of this study is that an intervention that addresses both dietary and personal care product
phthalate exposures can result in an even greater decrease in urinary phthalate metabolites.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05804019 -
Nutritional and Physical Activities for Overweight and Obese Older Adults
|
N/A | |
| Recruiting |
NCT05676229 -
Probiotic Blend in Reducing Anthropometric Measurements in Obese Adults
|
Phase 2 |