bioavailability study of folate in healthy subjects

Conditions: Healthy

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


Eligibility criteria:
inclusion criteria: * 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), exclusion criteria: * 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.

Keywords: folate bioavailability comparative study single dose