Measurement of Agricultural and Dietary Glyphosate Exposure Among Pregnant Women

NCT04155463 | Completed Results

• 1 other identifier: K01ES028745
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to understand whether and how pregnant women may be exposed to glyphosate, the active ingredient in a common herbicide. The researchers aim to assess glyphosate exposure among pregnant women in Idaho, and to attribute that exposure to agricultural and dietary sources. Pregnant women who live either near or far from glyphosate-treated fields will be recruited for study inclusion, and exposure will be assessed via urinary biomonitoring on a weekly basis throughout pregnancy. Each participant will also take part in a two-week dietary intervention, during which they will receive one week of organic food and one week of conventional food, in a crossover design. Urinary biomonitoring will occur on a daily basis during the dietary intervention phase. The researchers hypothesize that women who live near agricultural fields treated with glyphosate will have higher exposures than those who live in non-agricultural regions, and that consumption of an organic diet will reduce exposures in both groups. All study components will be completed with no face-to-face interaction to eliminate all coronavirus (COVID-19) related risks.

Conditions

Exposure to Herbicides

Keywords

Dietary Intervention; Glyphosate; Herbicide; Pregnancy; Agricultural Communities; Organic food

Outcome Measures

Primary Outcomes (1)

• Specific Gravity-adjusted Urinary Glyphosate Concentrations During Conventional and Organic Diet

  We collected 531 daily first morning void urine samples. We aliquoted 0.6 mL of each participant's seven daily urine samples to form a composite sample intended to represent each participant's mean glyphosate exposure during each week of the dietary intervention For all 39 participants there was one weekly composite urine sample from the conventional diet period and one weekly composite urine sample from the organic diet period. These 78 composite urine samples were analyzed for glyphosate concentrations and adjusted for urine specific gravity.

  One week conventional diet and one week organic diet

Study Arms (2)

Organic Diet, Then Conventional Diet:

EXPERIMENTAL

These participants first received an organic diet for one week. During that week, daily first morning void urine samples were collected. After a washout period of one day, these participants then received a conventional (non-organic) diet for one week. During that week, daily first morning void urine samples were collected. For each week, participants ordered all food they anticipated eating that week (up to $150) from a unique account with a local grocery store in accordance with either the organic diet or conventional diet. Study staff verified all food items corresponded with the dietary intervention that week, and then ordered the groceries to be delivered to the participant's home, when possible. For participants living in areas in which delivery was not available (generally rural areas), study staff picked up the food at the grocery store and delivered it to the participant's home.

Other: Organic Diet; Other: Conventional Diet

Conventional Diet, Then Organic Diet

EXPERIMENTAL

These participants first received a conventional (non-organic) diet for one week. During that week, daily first morning void urine samples were collected. After a washout period of one day, these participants then received an organic diet for one week. During that week, daily first morning void urine samples were collected. For each week, participants ordered all food they anticipated eating that week (up to $150) from a unique account with a local grocery store in accordance with either the organic diet or conventional diet. Study staff verified all food items corresponded with the dietary intervention that week, and then ordered the groceries to be delivered to the participant's home, when possible. For participants living in areas in which delivery was not available (generally rural areas), study staff picked up the food at the grocery store and delivered it to the participant's home.

Other: Organic Diet; Other: Conventional Diet

Interventions

Organic Diet OTHER

Participants receive one week of organic food. Organic food is certified through the USDA's National Organic Program as produced without the use of synthetic pesticides, including glyphosate.

Conventional Diet, Then Organic Diet; Organic Diet, Then Conventional Diet:

Conventional Diet OTHER

Participants receive one week of conventionally grown (non-organic) food.

Conventional Diet, Then Organic Diet; Organic Diet, Then Conventional Diet:

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be in the first trimester of pregnancy
• No diagnosis of gestational diabetes or other high risk pregnancy factors
• Consume an exclusively conventional diet with no intentions to switch to an organic diet
• Agree to refrain from applying residential glyphosate (Round Up) during the study
• Either live more than 10 miles or less than 1 mile from a glyphosate treated field

You may not qualify if:

• \- Occupational exposure to glyphosate, or live in a household with an individual with occupational glyphosate exposure

Sponsors & Collaborators

• Boise State University: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Boise State University

Boise, Idaho, 83725, United States

Location

Results Point of Contact

• Title: Dr. Cynthia Curl
• Organization: Boise State University

cynthiacurl@boisestate.edu

208-426-3924

Study Officials

• Cynthia Curl, PhD

  Boise State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Study participants will take part in a two-week dietary intervention. All participants will receive one week of organic food and one week of conventional food, randomized to order.

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: February 23, 2021
• Primary Completion: June 30, 2021
• Study Completion: December 28, 2021
• Last Updated: April 14, 2023
• Results First Posted: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)