Women of of childbearing age
Conditions
Interventions
Group 1: (6S)-5-Methyltetrahydrofolate dicholine, equimolar to 400 µg folic acid, oral, 1 tablet/day over 12 weeks
Sponsors
Sensory Effects, Inc.
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: - Healthy women of childbearing age - BMI: 17 - 30 kg/m2 - Written consent to participate in the study - Participant is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry and hematology - Able and willing to follow the study protocol procedures - If applicable, stable intake of chronic medication not interfering with the study of at least 3 months (i.e. thyroid hormone)
Exclusion criteria
Exclusion criteria: - Regular intake of drugs or supplements possibly interfering with this study in the last 3 months prior to the study and during the study (e.g. antacids, omeprazole, antifolate (MTX), vitamin C, or biotin (>5 mg/day), fat- or carbohydrate adsorbents for weight control, etc.) - Intake of folate supplements 3 months prior to and during the study - Anaemia defined as hemoglobin < 11g/dL - Intake of any antibiotic (example: Pyrimethamin or Trimethoprim) three weeks prior to screening as antibiotics interfere with the folate metabolism and may interfere with folate assay - Relevant disease history or presence of any severe medical disorder, potentially interfering with this study (e.g. gastro-intestinal diseases that may cause malabsorption such as Crohn’s disease, ulcerative colitis, coeliac disease or bariatric surgery, anti-depression medications, type 1 or type 2 diabetes, any current or past cancer except basal cell carcinoma of the skin, etc.) - A significant CVD event within the last 3 mo. incl. myocardial infarction, stroke, congestive heart failure, thrombosis People who adhere to a vegan diet for = 1 year or to a vegetarian diet or avoid eating meat for = 5 years, without using (regularly or temporally) a supplemental source of vitamin B12 (to exclude possible vitamin B12 deficiency and folate supplements masking B12 deficiency). - Significant changes in lifestyle or medications (within the last 3 mo.) or significant surgical intervention - Participants planning a significant change in their lifestyle or physical activity levels during the study - Drug, alcohol or other substance abuse - Pregnancy, breast feeding or intention to become pregnant during the study - Blood donation within 4 weeks prior to screening or during the study - Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study - Participants considered inappropriate for the study by investigators, including participants who are unable or unwilling to show compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants reaching the cut off values of red blood cell (RBC) folate concentrations of at least 906 nmol/L after 12 weeks of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in concentration of RBC folate from baseline (Day 43 and 85) Change in concentration of total folate in serum from baseline (Day 43 and 85) Change in concentration of homocystein from baseline (Day 43 and 85) Safety Parameter: Tolerability Adverse events (Day 1-85) | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed