Environmental Toxicants Avoidance Study

NCT04821752 | Suspended

• 1 other identifier: 20-1672
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pollution; Exposure; Glucose Intolerance; Glycemic Control

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (1)

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

  3 months

Study Arms (1)

Toxicant avoidance and glucose dysregulation

EXPERIMENTAL

To investigate whether or not the excretion of urinary toxicant metabolites is reduced by dietary modification and lifestyle intervention in people with glucose dysregulation; whether the participant's ranked glucose dysregulation correlates with the amount and/or type of toxic metabolites excreted at baseline; and whether the body's immediate response to glucose is improved by the reduction of toxicant burden.

Behavioral: Avoidance Education

Interventions

Avoidance Education BEHAVIORAL

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.

Toxicant avoidance and glucose dysregulation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Able to complete the remote informed consent process.
• Glucose dysregulation with HbA1c \>= 5.7% at baseline
• 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.
• Those not already eating a majority organic-food diet and drinking filtered water (\>50% by self-disclosure)

You may not qualify if:

• Use of insulin or insulin analog medications
• Planning to have elective surgery, diagnostic procedures, dental, or cosmetic procedures during the study period
• Unable or unwilling to modify dietary and lifestyle behaviors
• Those already eating a majority organic-food diet and drinking filtered water (\>50% by self-disclosure)

Sponsors & Collaborators

• Bastyr University: lead

Study Sites (1)

Bastyr University

Kenmore, Washington, 98028-4966, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Paola Costa-Mallen, PhD

  Bastyr University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Model Details: This is a single-arm trial with rolling enrollment

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 30, 2021
• Study Start: May 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)