Nutrient supply Healthy vegan volunteers
Conditions
Interventions
Group 1: The verum group receives the multinutrient preparation (ProVeg Essential +/1 capsule per day/ for ingredients and dosage see https://watsonnutrition.de/produkt/proveg-essentials-plus/) and th
Sponsors
Watson Nutrition
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • vegan diet for at least one year • age = 18 years
Exclusion criteria
Exclusion criteria: - smoking - pregnant or breastfeeding - diagnosed vitamin or mineral deficiency - diagnosed diseases affecting the metabolism (e.g. chronic gastritis, chronic intestinal dis-eases, thyroid diseases, other absorption disorders) - chronic medication use (exception: contraceptives are required and, if necessary, ex-cluded or adjusted) - supplementation of vitamin A/ß-carotene or selenium as well as (higher) consumption of Brazil nuts (e.g., max. 2 Brazil nuts per week are allowed) in the last three months before study entry - high dosage of vitamin B12 supplements (allowed e.g. max. 1 x per month = 1,000 µg or max. 1 x per week = 200 µg, max. 1 x per day < 10-50 µg or = 1 x daily vitamin B12 tooth-paste use) will be asked in the recruitment questionnaire, subjects with lowest possible supplementation will be selected preferentially - (regular) supplementation of vitamin B2, vitamin D, zinc, iron, choline, and/or n-3 fatty ac-ids in the last three months before study entry. - (regular) supplementation of iodine or regular consumption of iodine-containing seaweed in the last three months prior to study entry (exception: nori seaweed = 1 tsp/sheet per day); iodized salt consumption is permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| How does the daily use of the multinutrient supplement to be investigated over 16 weeks affect the vitamin A and selenium status (as well as vitamin B12 status) of vegans*? The following parameters are determined at the beginning and at the end of the intervention after 16 weeks. The sample size was calculated based on the main target variable vitamin A using G*Power 3.1.9.2. For this purpose, a study with 206 subjects from Switzerland was used, which investigated the serum retinol levels (analysis: HPLC) of vegans and mixed-foods people, since, to our knowledge, there is no study that has compared vitamin A-supplemented vegans and non-vitamin A-supplemented vegans. For the calculation, a difference in serum retinol levels between omnivorous (1,869 ± 436 nmol/l) and vegan (1,562 ± 408 nmol/l) fed participants* was found to be 307 nmol/l (Schüpbach et al. 2017). On this basis, a strong effect size (Cohen's d) of approximately 0.7 was anticipated. This results in a required case number of n = 25 per study group with a power of ß = 0.8 and a one-sided a = 0.05 (a priori one-sided t-test). For the second main outcome selenium, there are also no comparative studies between supplementing vegans* and non-supplementing vegans*. Therefore, a study with mixed-foods and (non-supplementing) vegans (Kadrabova et al. 1994) is used as a basis. Here, the less selective enzyme GPx (glutathione peroxidase) in plasma (compared to selenoprotein P) was used as a biomarker (analysis: mass spectrometry). With a difference between vegans* (223.9 ± 11.9µg/l) and omnivores (333.5 ± 10.6µg/l) of 109.6 µg/l and a power of ß = 0.8, a = 0.05 (a priori one-sided t-test), a required case number of n = 2 per group is obtained. For vitamin B12, an expected intervention effect on MMA concentration (analysis: gas chromatographic separation using unpo-lar capillary separation column and detection with SIM (in-house method) of at least 30% between verum and placebo group is assumed. This differenc | — |
Secondary
| Measure | Time frame |
|---|---|
| What is the effect of daily use of the multinutrient supplement under investigation for 16 weeks on the vitamin D, vitamin B2, zinc, iron and choline status of vegans*? How does the administration of an n-3 preparation with EPA/DHA and vitamin E over 16 weeks affect the fatty acid and vitamin E status of vegans? | — |
Countries
Germany
Contacts
Public ContactTim Zerback (geb. Ritzheim)
Forschungsinstitut für pflanzenbasierte Ernährung gGmbH (IFPE)
Outcome results
None listed