Environmental Toxicants Avoidance Study

Bastyr University20 enrolled

Overview

This study is designed to test whether non-persistent environmental chemicals (PECs) are elevated in people with glucose dysregulation. The primary aim is to measure whether this toxicant burden can be reduced using a dietary and lifestyle modification intervention. The secondary aim is to observe any changes in glucose response pre and post-intervention.

The primary aim will be measured using a commercially-available screening test for urinary toxicant metabolites. The toxicant burden will be measured by a percentile score of each metabolite and summing all percentile values. A risk level of each metabolite will be normalized by the percentile score in order to calculate the total toxic burden for an individual. Wilcoxon-ranked sum non-parametric calculations will be used to evaluate whether pre and post-intervention reduction has occurred. Because this is a single-arm trial, any reduction in the toxicant burden will be correlated with the relative improvement of the secondary endpoint and will be measured using Kendall's tau-beta ranked correlation. The secondary aim will assess each participant's fasting and post-prandial glucose response measured daily for throughout the 3-week trial. Because this study is not powered, the estimated man reduction from baseline cannot be estimated. Any reduction in blood glucose mean values will allow us to calculate an effect size for future investigation. The ranking of the improvement in glucose response (AUC) will be tested by ranking the reduction of the toxic burden by a correlation analysis using Kendall's tau-beta ranked correlation described above. Each participant is provided with a baseline in-person assessment, one midpoint education session and a final assessment session. Each participant will receive a standardized packet of information regarding dietary and lifestyle interventions which reduce toxicant exposures along with a water filter for home use and gift card to support the purchase of organic food during the trial. Questionnaires including a Medical Symptom Questionnaire, Weekly Stress Inventory and Knowledge Attitudes and Behavior Questionnaire will be administered pre and post-intervention.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pollution; Exposure Glucose Intolerance Glycemic Control

Interventions

Avoidance EducationBEHAVIORAL

Reduction of environmental toxins exposure from the diet will be achieved by switching to organic foods. Reduction of residential and occupational exposure to toxins from household cleaning products, cosmetics, personal care products, and other sources will be achieved by switching to safer products or avoidance of the toxic exposure.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 years old or older 2. Able to complete the remote informed consent process. 3. Glucose dysregulation with HbA1c \>= 5.7% at baseline 4. If hemoglobin A1c (HgA1c) is greater than 6.5% and the potential participant is not already receiving standard care for diabetes from a physician, participants must see their primary care provider for diabetes standard care before enrollment in the study. 5. Those not already eating a majority organic-food diet and drinking filtered water (\>50% by self-disclosure) Exclusion Criteria 1. Use of insulin or insulin analog medications 2. Planning to have elective surgery, diagnostic procedures, dental, or cosmetic procedures during the study period 3. Unable or unwilling to modify dietary and lifestyle behaviors 4. Those already eating a majority organic-food diet and drinking filtered water (\>50% by self-disclosure)

Locations (1)

Bastyr University

Kenmore, Washington, United States

Outcomes

Primary Outcomes

Change in percentile score of urinary excretion of toxicant marker metabolites pre and post three-week dietary and lifestyle intervention

Time frame: 3 months

Secondary Outcomes

Change in immediate glucose response measured by daily fasting and post-prandial blood glucose measurements.

A secondary endpoint is to observe each participant's glucose response throughout the 3-week trial period. Because this is not powered, the estimated mean reduction from the baseline to the ending of the trial cannot be estimated. Any reduction in the blood glucose mean values allows us to calculate the effect size for future investigation. The ranking of the improvement in glucose response (smaller AUC) is tested with the ranking of the reduction of toxic burden by a correlation analysis described the above.

Time frame: 3 months

Data from ClinicalTrials.gov

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