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临床试验/NCT03478345
NCT03478345已完成不适用

Taking Action to Thrive - A Healthy Lifestyle Intervention Pilot Study

George Washington University1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2018年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Changes in urinary endocrine disrupting chemical levels (especially phthalates)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •BMI >25 kg/m2
  • •willingness to participate in the 4-week long study
  • •English speaking
  • •capable of giving informed consent.

排除标准

  • •current smoker, or having quit smoking within the past 6 months
  • •currently or recently (past 6 months) pregnant or lactating, or planning to become pregnant in the next year
  • •engaging in >150 minutes exercise/week
  • •weight loss of ≥5 pounds over the past 6 months
  • •post-menopausal
  • •pre-existing chronic diseases
  • •use of medications known to alter body composition such as hormone replacements, oral contraceptives, and steroids
  • •homeless persons, or individuals who have active drug/alcohol dependence or abuse history
  • •Non-English speaking

研究组 & 干预措施

THRIVE Study

Experimental

干预措施: endocrine disruptor chemical reduction intervention (Behavioral)

结局指标

主要结局

Changes in urinary endocrine disrupting chemical levels (especially phthalates)

时间窗: Six weeks

Difference between urinary endocrine disrupting chemical levels from urine collected at the baseline study visit and urine collected at the final study visit.

Changes in body composition (weight and visceral adipose tissue volume)

时间窗: Six weeks

Difference between body weight and visceral adipose tissue volume (measured by dual x-ray absorptiometry) from baseline to final study visit.

次要结局

  • Correlation between dietary patterns and urinary endocrine disrupting chemical levels(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kimberly Robien

Associate Professor

George Washington University

研究点 (1)

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