obestas Obesity overweight
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: For all participants (study 1 and study 2): - Age 18-65 years - Male or female - Stable bodyweight ( 3kg/m2 between cotwins);For participants in study 2 (60 subjects): - Available information on genetic material as well as body weight - 15 Subjects with calculated low genetic predisposition risk for obesity and low BMI - 15 Subjects with calculated low genetic predisposition risk for obesity and high BMI - 15 Subjects with calculated high genetic predisposition risk for obesity and low BMI - 15 Subjects with calculated high genetic predisposition risk for obesity and high BMI
Exclusion criteria
Exclusion criteria: - Self reported type 2 diabetes mellitus - Irregularity of menstruation in premenopausal females defined as: cycle lengths shorter than 21 or longer than 35 days and/or menses periods shorter than 2 or longer than 8 days - Neurological illness - Psychiatric illness including eating disorders and depression - Malignancy - Pregnancy or breast feeding - Alcohol abuse defined as: for men > 21 units/week, for women > 14 units/week - History of claustrophobia or presence of metal objects/implants (because of MRI protocol) - Current or chronic use of the following medication: weight lowering agents (within 3 months before screening); antihyperglycemic agents (within 3 months before screening); glucocorticoids, centrally acting drugs, cytostatic drugs or immunomodulatory agents (alle of these within 2 weeks immediately prior to screening, because of the possible effects on cerebral functioning); opiates, narcotics, tranquilizers, and other potentially addictive medications - Visual disability, not correctable with glasses or contact lenses - Inability to understand the study protocol and/or inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study 1: The difference in neuronal activity in CNS reward and satiety circuits (including striatum, amygdala, orbitofrontal cortex, insula, hypothalamus) as represented by BOLD fMRI signal change from baseline (%) in response to food-related stimuli within 15 obesity discordant MZ twin pairs. Study 2: a. The difference in neuronal activity in CNS reward and satiety circuits (including striatum, amygdala, orbitofrontal cortex, insula, hypothalamus) as represented by BOLD fMRI signal change from baseline (%) in response to food-related stimuli between individuals at high verses those at low genetic obesity risk based on measured risk alleles from genome wide association studies. b. The difference in neuronal activity in CNS reward and satiety circuits (including striatum, amygdala, orbitofrontal cortex, insula, hypothalamus) as represented by BOLD fMRI signal change from baseline (%) in response to food-related stimuli between lean and obese subjects with either high or low genetic obesity risk. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters (study 1 and study 2): We will investigate the influence of environment and genetics on the following potential underlying mechanisms by performing additional tests in study 1 and study 2 respectively: 1. eating behavior measured as quantitative (kcal) and qualitative (energy density, macronutrient composition) dietary intake using a choice lunch buffet on the visit day and assessing dietary habits at home using the 24 hours recall method on two week days and one weekend day at home; 2. physical activity measured as metabolic equivalent of task (METs)-hours per week using seven-day ActiGraph triaxial accelerometry at home and using available longitudinal data from NTR surveys; 3. basal metabolic rate measured in kcal/day using oxygen consumption and carbon dioxide production measured with indirect calorimetry; 4. fasting plasma biomarkers (glucose, insulin, glucagon) measured in a fasting blood sample; 5. autonomic nervous system balance assessment based on measurements of heart rate variability (HRV), respiratory rate (RR) and respiratory sinus arrhythmia (RSA) using a portable electro- and impedance cardiogram (VU University Ambulatory Monitoring System, VU-AMS). Exploratory study parameters (study 1 and study 2): Conditional to available budget we will investigate the influence of environment and genetics on the following potential underlying mechanisms by performing additional tests in study 1 and study 2 respectively: 1. gut microbiota composition assessed by identifying microbial phylotypes using 16S rRNA molecule-based approaches of diagnostic analysis on collected fecal samples; 2. epigenetic changes by measuring DNA methylation in a blood sample; 3. exploratory fasting plasma biomarkers (leptin, GLP-1, PYY and ghrelin) will be determined in a fasting blood sample; 4. white matter tract integrity, functional connectivity of the brain and metabolic changes in the hypothalamus will be investigated using | — |
Countries
Netherlands