healthy volunteers
Conditions
Interventions
Group 1: Diet with a low proportion of healthful plant foods and a high proportion of animal foods (low ePDI and ehPDI)
Group 2: Diet with a medium proportion of healthful plant foods and a medium pro
Sponsors
Max Rubner-Institut
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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), which will be examined as a combined panel value. The three diets with different proportions of healthful plant foods (arm 1: low, arm 2: medium, arm 3: high) will be compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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), which will be examined as a combined panel value. Furthermore, the two diets with the same proportion but different nutritional qualities of plant foods (arm 3 versus arm 4) will be compared. Additional secondary endpoints will be assessed in all intervention groups: Multi-biomarker panel modeling will be adjusted for potential confounding variables: Age, sex, body composition, physical activity. Comparison of the concentrations of biomarkers in the multi-biomarker panel in different urine collection methods (24-hour urine collection, spot urine at defined times, pooled spot urine) to obtain information on the use of spot urine samples as an alternative to time-consuming 24-hour urine collections. Evaluation of the health effects of the different diets by extensive further metabolomic analysis in blood and urine samples as well as measurement of other health-related variables (e.g. clinical and chemical parameters such as blood lipid levels, glucose, metabolism-relevant hormones such as insulin, adipokines, lipid mediators). Characterization of study participants through assessment of habitual diet. Effects of diets with different amounts and nutritional qualities of plant foods on the composition and functionality of the gut microbiome. The integrity of the intestinal barrier by quantifying lipopolysaccharide binding protein (LBP) will be examined. | — |
Countries
Germany
Contacts
Public ContactJulia Renz
Max Rubner-Institut
Outcome results
None listed