Mercury Metabolism by Bacteria in Humans

NCT04060212 | Completed Results

• 2 other identifiers: 3842R01ES030940
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how the bacteria in your gut can improve the break-down and de-toxification of non-harmful levels of a naturally occurring form of mercury (methylmercury) that comes with eating fish. This research could help scientists and doctors understand whether or not mercury in fish that we are likely to eat poses any concern for the health of people.

Conditions

Mercury--Toxicology

Outcome Measures

Primary Outcomes (2)

• Mercury Elimination Rate Before Pre-biotic

  Mercury elimination rate will be determined for each individual at the beginning of the study, prior to any prebiotic administration. This determination will take place over the first 75 days of the study, wherein the first three fish meals are consumed, a eliminaiton period follows and then hair is sampled and analyzed. Time-resolved levels of mercury will be determined by longitudinal analysis of single hair strands using mass spectrometry methods. The values will be used to calculate the mercury elimination rate for each individual. The average elimination rate across the cohort before prebiotic will be reported. This total analysis will require approximately 2.5 months.

  2.5 months

• Mercury Elimination Rate After Pre-biotic

  Mercury elimination rate will be determined for each individual after commencing prebiotic self-administration for a period of 75 days, contemporaneously with the second set of fish meal consumption. This will begin approximately 6 months after the finish of the first round of fish meals and elimination (i.e. approximately 8.5 months after the participant starts the study). This second round will last approximately 2.5 months. Time-resolved levels of mercury will be determined by longitudinal analysis of single hair strands using mass spectrometry methods. The values will be used to calculate the mercury elimination rate for each individual. The average elimination rate across the cohort after prebiotic, from approximately 8.5 to 11 months will be reported.

  11 months

Secondary Outcomes (1)

• Change in Mercury Metabolism Ratio

  Baseline to 10 months

Study Arms (1)

All Participants

EXPERIMENTAL

All participant will eat 6 meals of tuna fish. All participants will take a prebiotic dietary supplement.

Other: Tuna fish; Dietary Supplement: prebiotic

Interventions

Tuna fish OTHER

Six meals of tunafish (\~200gms) will be consumed. Three meals will be consumed in a period of 14 days, and a subsequent 3 meals will be consumed within a 14 day period six month after the first 3 meals.

All Participants

prebiotic DIETARY_SUPPLEMENT

Prebiotin brand prebiotic will be consumed at 8grms/day for a period of 75 days. The prebiotic administration will begin with the second grouping of 3 fish meals.

All Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be 18-80 years in age.

You may not qualify if:

• Subject must be willing to comply with study procedures.
• Known allergy to fish.
• Pregnant or lactating women.
• Use of hair dyes or chemical treatments within the prior month and/or intent to use such treatments during the two trial periods. (Hair treatment during the washout period up to one month prior to the second trial is acceptable).
• Known gastrointestinal or renal disorders.
• Subjects with diminished mental capacity.
• Use of antibiotics within two months leading up to the study.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Coe GL, Krout IN, Munro-Ehrlich M, Beamish CR, Vorojeikina D, Colman DR, Boyd EJ, Walk ST, Rand MD. Assessing the role of the gut microbiome in methylmercury demethylation and elimination in humans and gnotobiotic mice. Arch Toxicol. 2023 Sep;97(9):2399-2418. doi: 10.1007/s00204-023-03548-7. Epub 2023 Jul 1.

  PMID: 37392210 DERIVED

MeSH Terms

Interventions

Prebiotics

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Results Point of Contact

• Title: Matthew Rand
• Organization: University of Rochester

matthew_rand@urmc.rochester.edu

585-275-5459

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 19, 2019
• Study Start: October 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: August 31, 2023
• Last Updated: October 4, 2023
• Results First Posted: November 2, 2022

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)