Effect of a vegan multinutrient supplement on the nutrient supply of vegans
Organizational Data
- DRKS-ID:
- DRKS00028151
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2022-07-27
- Last update in DRKS:
- 2023-11-10
- Registration type:
- Prospective
Acronym/abbreviation of the study
MultiVeg-Study
URL of the study
https://ifpe-giessen.de/multiveg-studie/
Brief summary in lay language
In a purely plant-based (vegan) diet, various nutrients are considered critical. These include in particular iron, zinc, iodine, selenium, vitamin B12, vitamin B2 and the long-chain omega-3 fatty acids. But other nutrients, such as vitamin A and branched-chain amino acids, are also currently being discussed as potentially critical. Critical in this context means that the average intake of these nutrients is more often below the reference values (e.g. D-A-CH reference values). Supplementation of various critical nutrients is recommended from a scientific point of view (e.g. vitamin B12). This is especially true if the daily diet is not optimally composed, the nutrient requirement is increased in certain phases of life, or the sufficient supply of all nutrients cannot always be ensured even with an optimized diet. In the meantime, there are various nutrient supplements on the market that are intended to help cover the nutrient requirements of a vegan diet. Scientific studies on the effectiveness and bioavailability of the nutrients contained are hardly available so far. Against this background, a micronutrient supplement (ProVeg Essentials+) and an n-3 supplement (ProVeg Omega 3+) of the Watson Nutrition brand are to be investigated. In doing so, the following questions will be answered: Main Question: 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*? Further questions: 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?
Brief summary in scientific language
A micronutrient preparation (ProVeg Essentials+) as well as a choline and n-3 preparation (soy lecithin, ProVeg Omega 3+) of the brand Watson Nutrition will be examined. The following questions will be answered: Main Question: 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*? Further questions: 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?
Health condition or problem studied
- Free text:
- Nutrient supply
- Free text:
- Healthy vegan volunteers
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 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 the choline (soy lecithin 10 g (2 enclosed measuring spoons) per day/ of which 2 g phosphatidylcholine/ of which 260 mg choline) and n-3 fatty acids preparation. (ProVeg Omega 3+/1 capsule per day/ for ingredients and dosage see https://watsonnutrition.de/produkt/proveg-omega-3-plus/) over a period of 16 weeks.
- Arm 2:
- The control group receives placebos (same appearance, same taste).
Endpoints
- Primary outcome:
- 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 β = 0.8 and a one-sided α = 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 β = 0.8, α = 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 difference is based on previous studies with vitamin B12-supplemented vegetarians* compared to non-supplemented vegetarians* (Siebert et al. 2017). With a β = 0.8 and α = 0.05 (a priori one-sided t-test), the number of cases is n = 35. Overall, a dropout of about 15% (experience from own study, by Siebert et al. 2017) is expected and thus a total case number of 40 per group is aimed for.
- Secondary outcome:
- 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?
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Placebo
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Data analyst
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Doctor's practice Bad Homburg
Recruitment period and number of participants
- Planned study start date:
- 2022-10-08
- Actual study start date:
- 2022-10-08
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 80
- Final Sample Size:
- 88
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- • vegan diet for at least one year • age ≥ 18 years
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/β-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.
Addresses
Primary Sponsor
- Address:
- Watson NutritionBenjamin PlobergerKulmer Straße 110783 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://watsonnutrition.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Forschungsinstitut für pflanzenbasierte Ernährung gGmbH (IFPE)M. Sc. Tim RitzheimAm Lohacker 235444 Biebertal/GießenGermany
- Telephone:
- 06409 – 3374 777
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ifpe-giessen.de
Contact for Public Queries
- Address:
- Forschungsinstitut für pflanzenbasierte Ernährung gGmbH (IFPE)M. Sc. Tim RitzheimAm Lohacker 235444 Biebertal/GießenGermany
- Telephone:
- 06409 – 3374 777
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ifpe-giessen.de
Principal Investigator
- Address:
- Forschungsinstitut für pflanzenbasierte Ernährung gGmbH (IFPE)M. Sc. Tim RitzheimAm Lohacker 235444 Biebertal/GießenGermany
- Telephone:
- 06409 – 3374 777
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ifpe-giessen.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Watson NutritionKulmer Straße 110783 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://watsonnutrition.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität GießenFrankfurter Straße 51-5335392 GießenGermany
- Telephone:
- +49-641-9942470
- Fax:
- +49-641-9942479
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-02-28
- Ethics committee number:
- AZ 57/22
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-06-28
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Studienprotokoll
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- Q2 2024
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry