Other specified vitamin deficiency diseases (vitamin B12 deficiency in vegetarians)
Conditions
Interventions
Group 1: Intervention group: Daily consumption of two portions of fermented chickpea products (containing naturally occurring vitamin B12 through fermentation) for a period of 12 weeks. Products inclu
Sponsors
Forschungsinstitut für pflanzenbasierte Ernährung gGmbH
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Age 18–50 years (men and women, target ratio 1:1) Lacto-ovo-vegetarian diet for at least 2 years For at least 3 months: few dairy products, eggs and/or fortified foods BMI 18.5–29.9 kg/m² Willingness to consume at least 2 chickpea products per day Willingness to attend 6 appointments at the study centre Physical and mental ability and sufficient German language skills to participate No change in dietary pattern during the intervention
Exclusion criteria
Exclusion criteria: Dietary patterns other than vegetarian (e.g., raw food, low-carb, vegan) Pregnancy or breastfeeding Smoking Chronic medication use (except contraceptives) Diagnosed vitamin or mineral deficiency Diagnosed conditions affecting metabolism (e.g., chronic gastritis, inflammatory bowel disease, thyroid disorders, other malabsorption disorders) Use of supplements containing vitamin B12, iron or zinc Regular consumption of Kanne Brottrunk or algae preparations containing chlorella and/or spirulina
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in vitamin B12 status of lacto-ovo-vegetarians after 12 weeks of intervention compared to the control group, measured by: - Holotranscobalamin (Holo-TC) [pmol/L] – at baseline (t0) and end of study (t1, week 12) - Methylmalonic acid (MMA) [nmol/L] – at baseline (t0) and end of study (t1, week 12) Blood samples taken in fasting state at the study centre. Analysis via linear mixed models or repeated-measures ANOVA; Bonferroni correction applied (significance level p < 0.025). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in iron and zinc status after 12 weeks of intervention compared to the control group, measured by: - Ferritin [µg/L] – at baseline (t0) and end of study (t1) - Haemoglobin (Hb) [g/dL] – at baseline (t0) and end of study (t1) - Zinc in whole blood [µmol/L] – at baseline (t0) and end of study (t1) In addition, high-sensitivity C-reactive protein (hs-CRP) is measured as a covariate. Assessment using linear mixed models or ANOVA-RM. Dietary intake assessed via 3-day weighed dietary record before t0 and t1; analysis using Nutrixo software (version 2024, Arcai Health). Statistical analysis with SPSS. | — |
Countries
Germany
Contacts
Public ContactMarkus Keller
Forschungsinstitut für pflanzenbasierte Ernährung (IPFE) gGmbH
Outcome results
None listed