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Measurement of Agricultural and Dietary Glyphosate Exposure Among Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155463
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : July 16, 2020
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Cynthia Curl, Boise State University

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.

Condition or disease Intervention/treatment Phase
Exposure to Herbicides Other: Organic Diet Other: Conventional Diet Not Applicable

Detailed Description:
This study focuses on human exposure to glyphosate, the single most commonly applied agricultural chemical in the world. Glyphosate is an herbicide, and is most commonly known as the active ingredient in "Round Up". Glyphosate has been declared a probable human carcinogen by the International Agency for Research on Cancer and multiple toxicological studies have further suggested potential neurological and developmental effects of glyphosate exposure at environmentally-relevant levels. However, despite its extensive use, frequent presence in food and environmental media, and potential toxicity, current exposure levels in human populations are not well documented. This proposed study aims to assess glyphosate exposure among a cohort of pregnant women and to quantify the relative contribution of agricultural and dietary sources of this exposure. Specifically, this project has two main aims. Under Aim 1, a cohort of 40 pregnant women will be recruited from urban areas >10 miles from the nearest glyphosate-treated field and agricultural areas <1 mile from the nearest glyphosate-treated field. Urinary analysis from these women will be used to indicate the number of repeated spot urine samples necessary to characterize glyphosate exposure over one trimester of pregnancy, and to quantify the effect of residential proximity to glyphosate-treated fields on exposure. Under Aim 2, these same 40 participants will then take part in a two week-long randomized cross-over design dietary intervention, during which participants will receive one week of exclusively organic food (grown without the use of synthetic pesticides, including glyphosate) and one week of exclusively conventional food, in random order. During the intervention, the researchers will collect daily spot urine samples from each participant to analyze for glyphosate exposure. The researchers hypothesize that during the time of year when glyphosate is actively applied, women living near glyphosate-treated fields will have higher exposures than those living further away. They also hypothesize that glyphosate exposure will be reduced among participants during randomization to the organic diet, but that this decrease will be larger among urban women than among those living near glyphosate-treated fields.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Measurement of Agricultural and Dietary Glyphosate Exposure Among Pregnant Women
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Experimental: Organic Diet
Participants will be allowed to order one week's worth of food from a grocery store website (capped by price), with the restriction that they may only order foods certified by the USDA as organically grown. This food will be delivered to the researcher's laboratory, packaged, and delivered to each participants' home. Participants will log their food intake using a custom food diary phone app provided by the study.
Other: Organic Diet
Participants will receive 7 days-worth of organic food. Organic food is certified through the USDA's National Organic Program as produced without the use of synthetic pesticides, including glyphosate.

Experimental: Conventional Diet
Participants will be allowed to order one week's worth of food from a grocery store website (capped by price), with the restriction that they may only order foods NOT certified by the USDA as organically grown. This food will be delivered to the researcher's laboratory, packaged, and delivered to each participants' home. Participants will log their food intake using a custom food diary phone app provided by the study.
Other: Conventional Diet
Participants will receive 7 days-worth of conventionally grown (non-organic) food.




Primary Outcome Measures :
  1. Change in urinary glyphosate concentrations during the organic diet period compared to the conventional diet period [ Time Frame: 2 weeks ]
    Urinary analysis will be completed on a weekly composite sample consisting of seven individual 1-mL aliquots from each study day during each week of the dietary intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be in the first trimester of pregnancy
  • Non-smoker
  • No history of gestational diabetes or other high risk pregnancy factors
  • Consume an exclusively conventional diet at the time of enrollment
  • 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

Exclusion Criteria:

  • Occupational exposure to glyphosate, or live in a household with an individual with occupational glyphosate exposure
  • Live between 1-10 miles from a glyphosate treated field

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155463


Contacts
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Contact: Cynthia Curl, PhD 208-426-3942 cynthiacurl@boisestate.edu

Sponsors and Collaborators
Boise State University
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Cynthia Curl, PhD Boise State University
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Responsible Party: Cynthia Curl, Associate Professor, Boise State University
ClinicalTrials.gov Identifier: NCT04155463    
Other Study ID Numbers: K01ES028745 ( U.S. NIH Grant/Contract )
K01ES028745 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cynthia Curl, Boise State University:
Dietary Intervention
Glyphosate
Herbicide
Pregnancy
Agricultural Communities
Organic food