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| ID | Type | Description | Link |
|---|---|---|---|
| K01ES028745 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Occupational exposure to glyphosate, or live in a household with an individual with occupational glyphosate exposure
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Curl, PhD | Boise State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boise State University | Boise | Idaho | 83725 | United States |
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As part of the longitudinal study, we conducted a two-week randomized crossover dietary intervention from June 16-June 30, 2021. 39 of the 40 participants took part in the dietary intervention (one participant was assigned to an arm but was out of town during the intervention). We randomly assigned participants to receive one week of either organic or conventional groceries, followed by one washout day, then one week of groceries of the opposite food type.
We recruited 40 pregnant women in their first trimester from Women, Infants, and Children (WIC) clinics in Idaho as part of a longitudinal study to examine urinary glyphosate concentrations during pregnancy. We enrolled participants between February 23 and June 3, 2021 and followed them until they gave birth between August 5 and December 28, 2021. Of the 58 individuals referred by WIC clinics, 53 (91%) were eligible; 40 (75%) of eligible individuals were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| First Intervention (1 Week) |
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| Washout (1 Day) |
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| Second Intervention (1 Week) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Organic Diet, Then Conventional Diet: | These participants first received an organic diet for one week, defined as food certified through the United States Department of Agriculture's National Organic Program as produced without the use of synthetic pesticides, including glyphosate. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | We geocoded each participant's address and verified the existence and location of all fields within a 0.5 km radius of their home. We report specific-gravity adjusted urinary glyphosate concentrations during the conventional and organic weeks for all participants and stratified by agricultural proximity, i.e. for participants living farther than 0.5 km of an agricultural field ("far-field") and living within 0.5 km of an agricultural field ("near-field"). | Posted | Geometric Mean | Inter-Quartile Range | ug/L | One week conventional diet and one week organic diet | Composite Urine Samples | Composite Urine Samples |
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Organic Diet | This arm refers to all 39 participants during their one week assigned to an organic diet (regardless of whether they were assigned to receive organic food the first week of the intervention or the second week of the intervention). During this time, participants received an organic diet for one week, defined as food certified through the USDA's National Organic Program as produced without the use of synthetic pesticides, including glyphosate. During that week, daily first morning void urine samples were collected. Participants ordered all food they anticipated eating that week (up to $150) from a unique account with a local grocery store in accordance with an organic diet. Study staff verified all food items corresponded with an organic diet, 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cynthia Curl | Boise State University | 208-426-3924 | cynthiacurl@boisestate.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2022 | Sep 15, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2022 | Sep 15, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 17, 2021 | Mar 8, 2022 | ICF_000.pdf |
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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.
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| Conventional Diet | Other | Participants receive one week of conventionally grown (non-organic) food. |
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| NOT COMPLETED |
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| BG001 | 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, defined as food certified through the United States Department of Agriculture National Organic Program as produced without the use of synthetic pesticides, including glyphosate.. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Participants could identify as more than one Race/Ethnicity | Count of Participants | Participants |
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| Highest Level of Education | Count of Participants | Participants |
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| Household income in previous year | Count of Participants | Participants |
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| Number living in household | Count of Participants | Participants |
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| Personally used herbicides at residence in last year | Count of Participants | Participants |
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| Someone else used herbicides at residence in last year | Count of Participants | Participants |
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| Type of herbicides used at residence in last year | This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.") | Count of Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | Conventional Diet | This arm refers to participants during their one week assigned to a conventional diet (regardless of whether they were assigned to receive conventional food the first week of the intervention or the second week of the intervention). During this time, participants received a conventional diet for one week. During that week, daily first morning void urine samples were collected. Participants ordered all food they anticipated eating that week (up to $150) from a unique account with a local grocery store in accordance with a conventional diet (i.e. no organic foods). Study staff verified all food items corresponded with a conventional diet, 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. |
| OG001 | Organic Diet | This arm refers to participants during their one week assigned to an organic diet (regardless of whether they were assigned to receive organic food the first week of the intervention or the second week of the intervention). During this time, participants received an organic diet for one week, defined as food certified through the United States Department of Agriculture National Organic Program as produced without the use of synthetic pesticides, including glyphosate. During that week, daily first morning void urine samples were collected. Participants ordered all food they anticipated eating that week (up to $150) from a unique account with a local grocery store in accordance with an organic diet. Study staff verified all food items corresponded with an organic diet, 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. |
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| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Conventional Diet | This arm refers to all 39 participants during their one week assigned to a conventional diet (regardless of whether they were assigned to receive conventional food the first week of the intervention or the second week of the intervention). During this time, participants received a conventional diet for one week. During that week, daily first morning void urine samples were collected. Participants ordered all food they anticipated eating that week (up to $150) from a unique account with a local grocery store in accordance with a conventional diet (i.e. no organic foods). Study staff verified all food items corresponded with a conventional diet, 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. | 0 | 39 | 0 | 39 | 0 | 39 |
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