Measurement of Agricultural and Dietary Glyphosate Exposure Among Pregnant Women

Exposure to Herbicides Clinical Trial

Official title:

Measurement of Agricultural and Dietary Glyphosate Exposure Among Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155463
• Other study ID #: K01ES028745
• Secondary ID: K01ES028745
• Status: Completed
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: December 28, 2021

Study information

• Verified date: April 2023
• Source: Boise State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 28, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Exposure to Herbicides

Intervention

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

Locations

Country	Name	City	State
United States	Boise State University	Boise	Idaho

Sponsors (2)

Lead Sponsor	Collaborator
Boise State University	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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