Measurement of Agricultural and Dietary Glyphosate Exposure Among Pregnant Women

April 13, 2023 updated by: Cynthia Curl, Boise State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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. 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. Weekly urine samples collected from these women throughout their pregnancies will be used to analyze glyphosate exposure. These same 40 participants will also 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 glyphosate exposure related to diet. 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. The researchers have taken extra precautions to eliminate all COVID-specific risks. There will be no face-to-face contact between research staff and study participants throughout the entire study. Interactions between researchers and study participants will take place through videos, emails, texts, and/or phone calls. All urine samples will be left for researchers to pick up at a predetermined location and time, and all groceries will be delivered to participants' home and left at their front door.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Boise, Idaho, United States, 83725
        • Boise State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Organic Diet, Then Conventional Diet:

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
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.
Other: Conventional Diet
Participants receive one week of conventionally grown (non-organic) food.
Experimental: Conventional Diet, Then Organic Diet

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
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.
Other: Conventional Diet
Participants receive one week of conventionally grown (non-organic) food.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Specific Gravity-adjusted Urinary Glyphosate Concentrations During Conventional and Organic Diet
Time Frame: One week conventional diet and one week 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boise State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Environmental Health Sciences (NIEHS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cynthia Curl, PhD, Boise State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K01ES028745 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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