Obesity, diabetes, and heart disease Nutritional, Metabolic, Endocrine
Conditions
Interventions
Current interventions as of 09/02/2024:
Study centered on energy expenditure measurements to be conducted according to three protocols:
I. Oral glucose tolerance test (OGTT) will be performed accor
ingested within 5 minutes).
II. Moderately high (24-25%) protein test meals will be provided. The test meal will consist of a simple breakfast meal base (two slices of toast and a milk-based drink to
ingested within 5 minutes).
Low (11-12%) and high (24-25%) protein test meals will be provided. The test meal will consist of a simple breakfast meal base (two slices of toast and a milk-based drink
Sponsors
Swiss National Science Foundation (SNSF)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 09/02/2024: 1. Young men and women (18-35 years old) 2. Healthy (as determined from medical history) 3. Non-obese, body mass index (BMI) < 30kg/m2 4. Non-smokers 5. Birth weight in the range of 1.5 – 4 kg _____ Previous inclusion criteria: 1. Young men and women (18-35 years old) 2. Healthy (as determined from medical history) 3. Non-obese, body mass index (BMI) < 30kg/m2 4. Non-smokers 5. Birth weight in the range of 1.5 – 3.5 kg
Exclusion criteria
Exclusion criteria: 1. Subjects born very premature defined as less than 28 weeks of gestation 2. Subjects who were treated for short stature (e.g. with growth hormone therapy) 3. Subjects taking medications that may alter body temperature, and any other condition that might impair the subject’s ability to participate in the study 4. Competition athletes, smokers, or overtly sedentary, or have eating disorders 5. Subjects who fear or have adverse reactions to cannulation 6. Subjects with a history of alcohol or any other drug abuse 7. Weight loss > 5% during 6 weeks prior to inclusion in the study 8. Pregnant and lactating women or females who desire to become pregnant over the study period (a pregnancy test is performed prior to each experimental protocol) 9. Subjects with gastro-intestinal complications, and fulfilling the official contraindications for the ingestion of the telemetry pill such as those diagnosed for diverticulitis, inflammatory bowel disease, gag reflex disorders or impairments, previous gastrointestinal surgery, hypo-motility of the gastrointestinal tract 10. Any person who might undergo magnetic resonance imaging (MRI) scanning while the telemetry pill is within the body, or having a cardiac pacemaker or another implanted electro-medical device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 09/02/2024: The following measurements will be taken only once as this is an acute response study and does not involve any follow-up: 1. Energy expenditure (EE) in the pre- and post-prandial states, assessed at rest in a comfortably seated position by gas exchange (using indirect calorimetry) – measurements will be performed 30 min before and for 2 and 3 hours after glucose drink and the meal, respectively. 2. EE in response to standardized low-intensity exercises measured by indirect calorimetry after 30 min of cycling on a bicycle ergometer and intermittent leg press over 40 min 3. Core body temperature measured by telemetry using ingested pill-sized sensors over 24 hours after sensor ingestion 4. Blood glucose and insulin measured during the oral glucose tolerance test after 30 min baseline and at 30, 60, 90, 120 min post-glucose drink (75 g glucose dissolved in 300 ml water); blood insulin will be measured by using an ELISA assay kit, whilst glucose will be measured by the reference method with hexokinase Glucose HK Gen 3 _____ Previous primary outcome measure: The following measurements will be taken only once as this is an acute response study and does not involve any follow-up: 1. Energy expenditure (EE) in the pre- and post-prandial states, assessed at rest in a comfortably seated position by gas exchange (using indirect calorimetry) – measurements will be performed 30 min before and for 3 hours after the meal 2. EE in response to standardized low-intensity exercises measured by indirect calorimetry after 30 min of cycling on a bicycle ergometer and intermittent leg press over 40 min 3. Core body temperature measured by telemetry using ingested pill-sized sensors over 24 hours after sensor ingestion 4. Blood glucose and insulin measured during the oral glucose tolerance test after 30 min baseline and at 30, 60, 90, 120 min post-glucose drink (75 g glucose dissolved in 300 ml water); blood insulin will be measured by | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/02/2024: The following measurements will be taken only once as this is an acute response study and does not involve any follow-up: 1. Respiratory quotient, measured using indirect calorimetry as per EE above 2. Anthropometry and body composition 3. Cardiovascular health and function 4. Potential sex-related differences _____ Previous secondary outcome measures: The following measurements will be taken only once as this is an acute response study and does not involve any follow-up: 1. Respiratory quotient, measured using indirect calorimetry as per EE above | — |
Countries
Switzerland
Outcome results
None listed