NCT02299778CompletedPhase 1
Is Bacterially-Synthesized Folate Absorbed Across the Colon of Humans?
The Hospital for Sick Children2 sites in 1 country10 target enrollmentStarted: April 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Change in isotopic folate overtime in blood
Study Overview
Brief Summary
The purpose of this study is to determine whether folate produced by bacteria that live in our colon can be absorbed in human colon using a stable isotope method. This study would lead a better understanding of the bioavailability of colonic bacterially-synthesized folate and its quantitative contribution to whole body folate homeostasis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18-65 years;
- •overall healthy
Exclusion Criteria
- •<18 years or >65 years
- •chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, haematological or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism
- •regular use of medications affecting gastrointestinal pH, motility or folate absorption/metabolism (eg. antiacids, laxatives, phenytoin, sulfasalzine, phenobarbital, primidone, cimetidine, proton pump inhibitors [such as Nexium] and antibiotics [such as Sulfonamides] or nonsteroidal anti-inflammatory drugs [NSAIDS, such as aspirin/ibuprofen])
- •consumption of >1 drink/day of alcohol on a regular basis or current smoking (last 6 months)
- •planning a pregnancy, pregnant, breast feeding or the use of high-dose estrogen oral contraceptives/hormone replacement therapy
- •known sensitivity to sunscreens containing ultraviolet B filters and/or PABA
- •difficulty with swallowing large pills or providing venous blood samples
Arms & Interventions
1mg of 13C6-p-aminobenzoic acid
Experimental
Intervention: 13C6-p-aminobenzoic acid (Dietary Supplement)
Outcomes
Primary Outcomes
Change in isotopic folate overtime in blood
Time Frame: Baseline (day 1), Days 2-4 ( 0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr)
Change in isotopic folate overtime in urine
Time Frame: Day 1 (0-24hr), Day 2 (25-48hr), Day 3 ( 49-72hr), Day 4 (73-96hr)
Secondary Outcomes
- Folate intake(Day1-4)
- Fiber intake(Day1-4)
Investigators
Deborah O'Connor
Senior Associate Scienitst
The Hospital for Sick Children
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 1
Folate Absorption Across the Large IntestineHealthyNCT00941174The Hospital for Sick Children9
Active, not recruiting
Not Applicable
Assessing Colonic Folate Absorption & MetabolismFolateNCT03421483The Hospital for Sick Children24
Completed
Early Phase 1
Gut Flora Dependent Metabolism of Dietary Phosphatidylcholine and Cardiovascular DiseaseNutritionNCT01519310The Cleveland Clinic4
Completed
Not Applicable
Where is the Initial Site of Biotransformation of Folates in Humans?HealthyNCT02135393Newcastle-upon-Tyne Hospitals NHS Trust6
Recruiting
Not Applicable
Determination of folate bioavailability in fermented dairy productsMTHFR- genes, content of homocysteine, content of hemoglobin, vitamin B12 levelDRKS00028996ehrstuhl für Analytische Lebensmittelchemie6