Skip to content

Randomised, double-blind, controlled, crossover intervention study to investigate the health-promoting effects of a Brassica oleracea-based diet in humans (pilot study)

Randomised, double-blind, controlled, crossover intervention study to investigate the health-promoting effects of a Brassica oleracea-based diet in humans (pilot study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037133
Enrollment
50
Registered
2025-09-03
Start date
2026-01-13
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health promoting potential

Interventions

Group 1: B. oleracea smoothie, low biodiversity, for 4 days (once a day), special diet during washout (14 days before intervention) and during intervention Group 2: B. oleracea smoothie, high biodiver

Sponsors

Universität Augsburg - Medizinische Fakultät, Professur für die Erfoschung umweltebezogener Wirkmechanismen auf die Gesundheit
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 80 Years

Inclusion criteria

Inclusion criteria: BMI 18.5–30 Non-smoker for at least 10 years Women: confirmed postmenopause (>12 months since last menstruation) Able to understand instructions in German Dietary habits: willingness, if possible, to eat all main meals together during the intervention phases; no eating disorders Compliance: willingness to document all meals during the intervention phases using the GDPR-compliant nutrition app “LogMeal” or as a dietary protocol, and to follow the study requirements Health status: generally good physical and mental health; not in need of care Medication status: no use of antibiotics within the last 3 months before the start of the main study “washout phase”; no use of pre- or probiotics as dietary supplements during the main study; no use of proton pump inhibitors (PPIs), laxatives, metformin, or diuretics during the main study; no polypharmacy (<5 prescription medications/day)

Exclusion criteria

Exclusion criteria: Age: under 55 or over 80 years BMI 30 Smoker or non-smoker for less than 10 years Inability to understand instructions in German Dietary habits: existing strict vegan, ketogenic, or extremely high-fiber diet; eating disorders Health status: severe acute or chronic diseases (e.g., Crohn’s disease, ulcerative colitis, active cancer, severe heart, liver, or kidney disease, autoimmune diseases), need for care, or severe cognitive impairments Medication: use of antibiotics within the last 3 months before the start of the main study; use of pre- or probiotics as dietary supplements during the main study; use of PPIs, laxatives, metformin, or diuretics during the main study; polypharmacy (>5 prescription medications/day) Occupational burden: active shift work Known allergy to Brassicales

Design outcomes

Primary

MeasureTime frame
Changes of the gut microbiome (Measured on day 7, 14 and 20)

Secondary

MeasureTime frame
Microbiome-associated normal tissue function, measured in urine and exhaled breath condesate (Urine measurements on day 15, 19 and 20, exhaled breath condensate on day 15 and 19)

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026