Validating a multi-biomarker panel for the assessment of quantity and quality of plant foods in the diet
- Conditions
- healthy volunteers
- Registration Number
- DRKS00032738
- Lead Sponsor
- Max Rubner-Institut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 68
•Women and men, 18 years or older
•Volunteers who are able to comply with the study terms
•Parameters of liver and kidney function, carbohydrate and lipid metabolism without pathological significance
•Non-smokers
•Omnivorous diet (mixed eater)
•Written informed consent to participate in the study
•Diseases affecting the absorption, digestion, metabolism or excretion of nutrients
•Acute or chronic infectious diseases
•Tumors requiring therapy
•History of bariatric surgery
•History of gastrointestinal tract surgery affecting absorption, digestion, metabolism, or excretion of nutrients
•History of pancreas surgery
•Cholecystectomy
•Acute/regular intake of medications resulting in energy or nutrient malabsorption
•Allergy/intolerance to any food or food ingredient in the study diet
•Use of dietary supplements < 2 weeks prior to study period
•Use of antibiotics < 3 months prior to study period
•blood donation during or < 4 weeks prior to study period
•Pregnancy and breastfeeding
•Illegal drug use
•Alcohol or drug abuse
•Participation in other clinical trials that may affect the outcome of this study
•Individuals living in a care facility
•Individuals deprived of their liberty by court or administrative order
•Individuals who are not expected to comply with the terms of the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the concentrations of biomarkers in the multi-biomarker panel in urine and blood samples from study participants during the intervention period (from visit 2 to visit 4). They are examined as a combined panel value. The three diets with different proportions of healthful plant foods (group 1: low, group 2: medium, group 3: high) will be compared.
- Secondary Outcome Measures
Name Time Method