Trial document




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  DRKS00028151

Trial Description

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Title

Effect of a vegan multinutrient supplement on the nutrient supply of vegans

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Trial Acronym

MultiVeg-Study

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URL of the Trial

https://ifpe-giessen.de/multiveg-studie/

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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?

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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?

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00028151
  •   2022/07/27
  •   [---]*
  •   no
  •   Approved
  •   AZ 57/22, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Nutrient supply
  •   Healthy vegan volunteers
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Interventions/Observational Groups

  •   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.
  •   The control group receives placebos (same appearance, same taste).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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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.

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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?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2022/10/08
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• vegan diet for at least one year
• age ≥ 18 years

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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.

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Addresses

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    • Watson Nutrition
    • Mr.  Benjamin  Ploberger 
    • Kulmer Straße 1
    • 10783  Berlin
    • Germany
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    • Forschungsinstitut für pflanzenbasierte Ernährung gGmbH (IFPE)
    • Mr.  M. Sc.  Tim  Ritzheim 
    • Am Lohacker 2
    • 35444  Biebertal/Gießen
    • Germany
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    • Forschungsinstitut für pflanzenbasierte Ernährung gGmbH (IFPE)
    • Mr.  M. Sc.  Tim  Ritzheim 
    • Am Lohacker 2
    • 35444  Biebertal/Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Watson Nutrition
    • Mr.  Benjamin  Ploberger 
    • Kulmer Straße 1
    • 10783  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.