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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
12
Active form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) glucosamine salt
Active form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) calcium salt, crystal form 1
Active form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) calcium salt, crystal form 2
Biofortis
Saint-Herblain, France
Area under the curve (AUC) 0-24 hours of serum 5-MTHF concentrations
Comparison of AUC0-24 hours of serum 5-MTHF concentrations between the 3 study products
Time frame: 0-24 hours
Area under the curve (AUC) 0-24 hours of serum total folate concentrations
Comparison of AUC0-24 hours of serum total folate concentrations between the 3 study products
Time frame: 0-24 hours
Area under the curve (AUC) 0-8 hours of serum 5-MTHF and total folate concentrations
Comparison of AUC0-8 hours of serum 5-MTHF and total folate concentrations between the 3 study products
Time frame: 0-8 hours
Area under the curve (AUC) 0-infinity of serum 5-MTHF and total folate concentrations
Comparison of AUC0-infinity of serum 5-MTHF and total folate concentrations between the 3 study products
Time frame: 0-24 hours
Peak plasma concentrations (Cmax) of serum 5-MTHF and total folate
Comparison of peak plasma concentrations (Cmax) of serum 5-MTHF and total folate between the 3 study products
Time frame: 0-24 hours
Half-life time of serum 5-MTHF and total folate
Comparison of half-life time of serum 5-MTHF and total folate between the 3 study products
Time frame: 0-24 hours
Mean Residence Time (MRT) of serum 5-MTHF and total folate
Comparison of Mean Residence Time (MRT) of serum 5-MTHF and total folate between the 3 study products
Time frame: 0-24 hours
Area under the curve (AUC) 0-24 hours of serum 5-MTHF and total folate concentrations adjusted on sex
Comparison of AUC0-24 hours of serum 5-MTHF and total folate concentrations between the 3 study products after adjustment by sex
Time frame: 0-24 hours
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