Trial Outcomes & Findings for Mercury Metabolism by Bacteria in Humans (NCT NCT04060212)
NCT ID: NCT04060212
Last Updated: 2023-10-04
Results Overview
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.
COMPLETED
NA
36 participants
2.5 months
2023-10-04
Participant Flow
Participant milestones
| Measure |
All Participants
All participant will eat 6 meals of tuna fish. All participants will take a prebiotic dietary supplement.
Tuna fish: 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.
prebiotic: 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.
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|---|---|
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Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
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29
|
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Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
All Participants
All participant will eat 6 meals of tuna fish. All participants will take a prebiotic dietary supplement.
Tuna fish: 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.
prebiotic: 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.
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|---|---|
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Overall Study
Withdrawal by Subject
|
7
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Baseline Characteristics
Mercury Metabolism by Bacteria in Humans
Baseline characteristics by cohort
| Measure |
All Participants
n=36 Participants
All participant will eat 6 meals of tuna fish. All participants will take a prebiotic dietary supplement.
Tuna fish: 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.
prebiotic: 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.
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|---|---|
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Age, Continuous
|
32.6 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
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Region of Enrollment
United States
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36 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2.5 monthsMercury 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.
Outcome measures
| Measure |
All Participants
n=29 Participants
All participant will eat 6 meals of tuna fish. All participants will take a prebiotic dietary supplement.
Tuna fish: 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.
prebiotic: 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.
|
|---|---|
|
Mercury Elimination Rate Before Pre-biotic
|
48.5 days
Standard Deviation 14.5
|
PRIMARY outcome
Timeframe: 11 monthsMercury 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.
Outcome measures
| Measure |
All Participants
n=29 Participants
All participant will eat 6 meals of tuna fish. All participants will take a prebiotic dietary supplement.
Tuna fish: 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.
prebiotic: 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.
|
|---|---|
|
Mercury Elimination Rate After Pre-biotic
|
49.1 days
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Baseline to 10 monthsPopulation: This data was not collected because a flaw was discovered in the analytical design.
Mercury metabolism ratio, i.e. conversion of methylmercury to inorganic mercury, will be determined for each individual before and after prebiotic administration. The difference in average metabolism ratio across the cohort before and after prebiotic will be reported. Mercury elimination ratios will be measured in stool samples using mass spectrometry methods.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=36 participants at risk
All participant will eat 6 meals of tuna fish. All participants will take a prebiotic dietary supplement.
Tuna fish: 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.
prebiotic: 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.
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|---|---|
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Gastrointestinal disorders
nausea
|
8.3%
3/36 • 11 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place