Measurement of Agricultural and Dietary Glyphosate Exposure Among Pregnant Women
Condition: Exposure to Herbicides
Study type: Interventional

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.
    

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.
    

Intervention name(s): Organic Diet; Conventional Diet
Intervention type(s): Other; Other
Intervention description(s): 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.; Participants receive one week of conventionally grown (non-organic) food.
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
Keywords: Dietary Intervention; Glyphosate; Herbicide; Pregnancy; Agricultural Communities; Organic food