NCT05699473

Bioavailability Study of Folate in Healthy Subjects

A Double Blind, Randomized, Cross-over, Comparative Bioavailability Study of 3 Different Forms of Folate in Healthy Subjects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Lesaffre International · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-01-12
• Primary completion: 2023-05-06
• Completion: 2023-05-06
• First posted: 2023-01-26
• Last updated: 2024-01-05

Locations

1 site across 1 country: France