Bacterially-synthesized Folate Absorption Across the Large Intestine

NCT02299778 | Completed Phase 1 DMC

• 1 other identifier: 1000026022
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Change in isotopic folate overtime in blood

  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

  Day 1 (0-24hr), Day 2 (25-48hr), Day 3 ( 49-72hr), Day 4 (73-96hr)

Secondary Outcomes (2)

• Folate intake

  Day1-4

• Fiber intake

  Day1-4

Study Arms (1)

1mg of 13C6-p-aminobenzoic acid

EXPERIMENTAL

Dietary Supplement: 13C6-p-aminobenzoic acid

Interventions

13C6-p-aminobenzoic acid DIETARY_SUPPLEMENT

1mg of 13C6-p-aminobenzoic acid

Eligibility Criteria

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

You may qualify if:

• years;
• overall healthy

You may not qualify if:

• \<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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Officials

• Deborah L O'Connor, RD, PhD

  The Hospital for Sick Children, Toronto, ON, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Scienitst

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: November 24, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

CA (1)