Promoting Immune Health by Intermittent Fasting: a Pilot Study (TIGER)
Metabolic Syndrome, HEALTHY VOLUNTEERS, Time Restricted Feeding
About this trial
This is an interventional other trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria metsyn: BMI 30 to 43 kg/m2 HOMA-IR index larger/same as 2.5 And At least 3 out of 5 NCEP (National Cholesterol Education Program) metabolic syndrome criteria: Fasting plasma glucose ≥ 6.1 mmol/l, Triglycerides≥1.7mmol/l, Waist-circumference>102cm, HDL-cholesterol<1.04mmol/l, Bloodpressure≥130/85mmHg). Inclusion healthy volunteers Body mass index (BMI) 18 to 25 kg/m2, Waist circumference between 79 cm and 94 cm and HOMA-IR index: ≤ 2.0 (measured as fasting insulin (pmol/L) x fasting glucose (mmol/L)) / 135) Exclusion criteria; (all) Excessive weight loss of >10% in the last months; Use of any medication, including proton pomp inhibitors and antibiotics in the past three months; Cholecystectomy; Untreated GI disease/abnormal bowel habits; Plasma aspartate aminotransferase and alanine aminotransferase are 2.5 times or more the upper limit of the normal range; A history of cardiovascular event (MI or pacemaker implantation); A history of heavy alcohol use (>12 to 15 g of alcohol per day, or >12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits); A dependency on alcohol or unable to pause the consumption of alcohol during the study period. An (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240); Unmotivated or not able to adhere to a specific diet; History of eating disorder; Night workers or people with deviant day/night rhythm; Pregnant, trying to get pregnant or breast feeding at inclusion; Irregular menstrual cycle; Hormonal replacement therapy (other than oral contraceptives).
Sites / Locations
- Amsterdam UMC location AMCRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
daily time-restricted eating (TRE) for 2 weeks
control protocol for each two weeks
Subjects will be instructed to consume all calories needed for a stable weight (based on their resting energy expenditure) in either one meal per day (TRE; between 10:00-11:00; a protein snack at 13 h) or in three meals per day (control; breakfast, lunch and dinner). Prior to the intervention, a dietician will instruct subjects on nutritional intake based on their caloric need measured by indirect calorimetry (see indirect calorimetry). During the intervention, subjects will fill in online or written dietary diary (e.g. eetmeter) and a physical activity diary. Halfway the intervention, a telephone consult with a dietician will take place
Subjects will be instructed to consume normal diet/calories. Prior to the intervention, a dietician will instruct subjects on nutritional intake based on their caloric need measured by indirect calorimetry (see indirect calorimetry). During the intervention, subjects will fill in online or written dietary diary (e.g. eetmeter) and a physical activity diary. Halfway the intervention, a telephone consult with a dietician will take place