Healthy volunteers with B12 marginal deficiency Nutritional, Metabolic, Endocrine Healthy volunteers with B12 marginal deficiency
Conditions
Interventions
Participants are enrolled in the study after they complete a specific questionnaire and medical examination to determine eligibility. Participants are then randomly allocated to one of two groups base
Sponsors
Phoenix S.R.L. - LongLife Nutritional Supplements
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy men/women (20-60 years of age) 2. Moderate smoking (about 5-6 cigarette/day) 3. Moderate physical activity (25-30 min per day of brisk walk or jog) 4. Moderate alcohol consumption (up to 14 drinks per week) 5. Plasma levels of vitamin B12 lower than 220 pmol / L 6. Follow a vegan diet 7. No regular intake of drugs (for any type of disease) 8. Non allergic subjects
Exclusion criteria
Exclusion criteria: 1. History of cardiovascular, coronary, diabetes, hepatic, renal, or gastrointestinal diseases. 2. Use of any drugs, medications at least one month before the beginning of the experiment. 3. Use of vitamin B12 supplements at least one year before the beginning of the experiment. 4. Omnivore subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nutritional status (vitamin B12, holotranscobalamin, methylmalonic and homocysteine concentrations) are measured using blood samples at baseline, day 15, day 30, day 60 and day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete blood count is measured using blood samples at baseline, day 15, day 30, day 60 and day 90 2. Serum levels of folic acid is measured using blood samples at baseline, day 15, day 30, day 60 and day 90 3. Vitamin B6 is measured using blood samples at baseline, day 15, day 30, day 60 and day 90 | — |
Countries
Italy
Outcome results
None listed