Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Participants are randomized to two groups: high-satiety and low-satiety food groups
All participants will receive a very low calorie diet for 8 weeks. The weight maintenance period is
Sponsors
University of Eastern Finland (Finland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Body mass index 30?40 kg/m2 2. Age 30?65 years
Exclusion criteria
Exclusion criteria: 1. BMI >40 or 16, men > 24 portions/week). 9. No other diseases, medications, or life situations that would prevent them from successfully completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Body weight measured by a digital scale at baseline, 8, 12, 24 weeks and at follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anthropometry and body composition: height measured using a wall-mounted stadiometer at screening; waist circumference using a calibrated tape measured at baseline, 8, 12 and 24 weeks; body composition using fat mass and fat-free mass by bioelectrical impedance measured at baseline, 8, 12 and 24 weeks 2. Eating behaviour by questionnaires at baseline, 12 and 24 weeks 3. Glucose and lipid metabolism and satiety-related hormones measured at baseline, 8, 12 and 24 weeks 3.1. Lipid metabolism: fasting serum HDL-, LDL-, total cholesterol, triglycerides and free fatty acids samples 3.2. Glucose metabolism: fasting and 2-hour oral glucose tolerance test (time points 0 min, 30 min, 60 min and 120 min) plasma/serum glucose and insulin samples 3.3. Satiety-related hormones: fasting plasma ghrelin, leptin, peptide YY samples 4. Inflammatory markers: serum/plasma CRP, IL6, IL1ra, adiponectin samples measured at baseline, 8 and 24 weeks 5. Adipose tissue and peripheral blood mononuclear cell gene expression: optional, performed only for those who were willing to give the samples. Measured by adipose tissue biopsies from subcutaneous abdominal fat and peripheral blood mononuclear cells (PBMCs) isolated from anticoagulated peripheral blood samples measured at baseline, 8 and 24 weeks 6. Gut microbiota composition by taking fecal samples measured at baseline, 8 and 24 weeks | — |
Countries
Finland
Outcome results
None listed