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Bioavailability Study of Folate in Healthy Subjects

NCT05699473 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-01-05

No results posted yet for this study

Summary

The aim of this prospective interventional study is to compare the bioavailability of the 6S-5-methyltetrahydrofolate (5-MTHF) glucosamine salt versus two other forms of 5- MTHF calcium salts by measuring serum 5-MTHF responses after a single ingestion of equivalent doses of the three folate forms in humans.

The hypothesis of this study is that the test products 5-MTHF glucosamine and calcium salts have equivalent bioavailabilities in serum 5-MTHF as measured by the area under the curve over a period of 24 hours (AUC0-24h) after consumption of a single dose of 5-MTHF (400μg).

Participants will receive a single dose of each of the following products separated by a 7-day wash-out period:

* 5-MTHF glucosamine salt
* 5-MTHF calcium salt 1
* 5-MTHF calcium salt 2

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

5-MTHF glucosamine salt

Active form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) glucosamine salt

DIETARY_SUPPLEMENT

5-MTHF calcium salt 1

Active form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) calcium salt, crystal form 1

DIETARY_SUPPLEMENT

5-MTHF calcium salt 2

Active form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) calcium salt, crystal form 2

Sponsors & Collaborators

  • BioFortis

    collaborator OTHER

  • Soladis

    collaborator INDUSTRY

  • Lesaffre International

    lead INDUSTRY

Principal Investigators

  • Isabelle METREAU, MD · BioFortis

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2023-05-06
Completion
2023-05-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05699473 on ClinicalTrials.gov