healthy volunteers
Conditions
Interventions
Group 1: Diet with a low proportion of healthful plant foods (e.g. unprocessed fruits/vegetables, whole grain products, legumes, nuts, seeds) and a high proportion of animal-based foods
Group 2: Diet
Sponsors
Max Rubner-Institut
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: • BMI 18,5 – 30 kg/m² • non-smokers • omnivorous diet • signed informed consent
Exclusion criteria
Exclusion criteria: • acute diseases during trial period • acute/chronic diseases of gastrointestinal tract • diabetics • acute/regular intake of medication with effect on gastrointestinal tract (e. g. proton pump inhibitors) • bariatric operation • illegal drug use • chronic alcohol abuse • use of antibiotics = 3 month prior to study entry • applies to bioelectrical impedance analysis only: pacemaker, active prostheses, artificial heart/lung or portable medical devices (ECG) • persons with fluctuating body weight (changes of =5 kg/year) • pregnant or breastfeeding women • known allergy/intolerance against foods or food components • any kind of diagnosed eating disorder • institutionalized persons, subjects deprived of their liberty by judicial or administrative decision • participation in other clinical trials that may impact on outcome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Acceptance of dietary interventions - acceptance of meal plans - degree of satiety after meal consumption - palatability of meals • feasibility of dietary intervention in everyday life - expenditure of time - degree of difficulty in preparing the meals - personal assessment of potential feasibility if the intervention period was extended to 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| • Well-being of volunteers, before, during and after intervention, as well as its impact on the intervention • characterization of study population: age, gender, anthropometry (size, weight, body composition by bioelectrical impedance analysis), resting energy expenditure (indirect calorimetry; calculation by the Armbruster formula (2019)), physical activity (International Physical Activity Questionnaire, IPAQ) • drop-out rate • compliance (complete daily logs, weighing of left-overs (if applicable), adherence to scheduled visits at the study center) • implementation of dietary intervention: evaluation of feasibility by the study team: - energy adjustment of menus based on the following data: physical activity (IPAQ) and resting energy expenditure - expenditure of personnel and time for food logistics (purchase of foods, preparation of food packages) - expenditure of personnel and time for different examinations, check of examination schedule of visiting days | — |
Countries
Germany
Contacts
Public ContactStudienzentrum für Humanstudien
Max Rubner-Institut
Outcome results
None listed