Bioavailability Study of Folate in Healthy Subjects
- Conditions
- Healthy
- Interventions
- Dietary Supplement: 5-MTHF calcium salt 2Dietary Supplement: 5-MTHF glucosamine saltDietary Supplement: 5-MTHF calcium salt 1
- Registration Number
- NCT05699473
- Lead Sponsor
- Lesaffre International
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
- Body Mass Index (BMI) ≥18 and ≤25Kg/m²,
- For women: menopausal without hormone replacement therapy (HRT) or with HRT started from more than 3 months or non-menopausal with a negative blood pregnancy test and using reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study,
- Good general and mental health within the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
- Able and willing to participate to the study by complying with the protocol procedures as evidenced by his/her dated and signed informed consent form,
- Affiliated with a social security scheme,
- Agree to be registered on the subjects in biomedical research file.
After V1 biological analysis the subjects will be eligible to the study on the following criteria:
- Adequate folate status (serum folate between 10 and 45nmol/L, erythrocyte (RBC) folate between 405 and 952 nmol/L),
- Suffering from a metabolic disorder,
- Suffering from a severe chronic disease found to be inconsistent with the conduct of the study by the investigator,
- Suffering from diseases that could potentially interfere with folate absorption or metabolism,
- With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
- With a low venous capital of blood samples according to the investigator's opinion,
- Pregnant or was pregnant less than 6 months prior to the study, or lactating women or intending to become pregnant within 3 months ahead,
- Under treatment or regular use of treatment or dietary supplement which could significantly affect folate status or other study parameter(s),
- Use of supplements containing folate (i.e. folic acid, 5-MTHF) the last 3 months,
- With significant change in lifestyle, food habits, physical activity or medications in the 3 months before the V1 visit or not agreeing to keep them unchanged throughout the study,
- With a current or planned in the next 3 months' specific diet (hyper or hypocaloric, vegan, vegetarian...) or stopped less than 3 months before the study,
- With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator,
- Consuming more than 2 standard drinks of alcoholic beverage daily for men and women or not agreeing to keep his alcohol consumption habits unchanged throughout the study.
- Smoking,
- Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity,
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
- Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros,
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
- Presenting a psychological or linguistic incapability to sign the informed consent,
- Impossible to contact in case of emergency.
- Who made a blood donation in the 3 months before the V0 visit or intending to make it within 3 months ahead.
After V1 biological analysis the subjects will be non-eligible to the study on the following criteria:
- Presence of anemia (hemoglobin<12g/dL in women and 13g/dL in men),
- Vitamin B12 levels (serum cobalamin <148pmol/L),
- Serum total homocysteine levels≥15µmol/L,
- Serum creatinine >0,96mg/dL for women and >1,21mg/dL for men,
- Control record (Glycaemia, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, GGT, ASAT, ALAT, Urea and CBC) with clinically significant abnormality according to the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 5-MTHF calcium salt 2 5-MTHF calcium salt 2 1 single dose (400µg) 5-MTHF glucosamine 5-MTHF glucosamine salt 1 single dose (400µg) 5-MTHF calcium salt 1 5-MTHF calcium salt 1 1 single dose (400µg)
- Primary Outcome Measures
Name Time Method Area under the curve (AUC) 0-24 hours of serum 5-MTHF concentrations 0-24 hours Comparison of AUC0-24 hours of serum 5-MTHF concentrations between the 3 study products
- Secondary Outcome Measures
Name Time Method Area under the curve (AUC) 0-24 hours of serum total folate concentrations 0-24 hours Comparison of AUC0-24 hours of serum total folate concentrations between the 3 study products
Peak plasma concentrations (Cmax) of serum 5-MTHF and total folate 0-24 hours Comparison of peak plasma concentrations (Cmax) of serum 5-MTHF and total folate between the 3 study products
Half-life time of serum 5-MTHF and total folate 0-24 hours Comparison of half-life time of serum 5-MTHF and total folate between the 3 study products
Area under the curve (AUC) 0-infinity of serum 5-MTHF and total folate concentrations 0-24 hours Comparison of AUC0-infinity of serum 5-MTHF and total folate concentrations between the 3 study products
Mean Residence Time (MRT) of serum 5-MTHF and total folate 0-24 hours Comparison of Mean Residence Time (MRT) of serum 5-MTHF and total folate between the 3 study products
Area under the curve (AUC) 0-8 hours of serum 5-MTHF and total folate concentrations 0-8 hours Comparison of AUC0-8 hours of serum 5-MTHF and total folate concentrations between the 3 study products
Area under the curve (AUC) 0-24 hours of serum 5-MTHF and total folate concentrations adjusted on sex 0-24 hours Comparison of AUC0-24 hours of serum 5-MTHF and total folate concentrations between the 3 study products after adjustment by sex
Trial Locations
- Locations (1)
Biofortis
🇫🇷Saint-Herblain, France