Promoting Immune Health by Intermittent

2022.0697

The goal is to study the direct effects of long-term intermittent fasting on immune cell populations in the blood, combined with analyses of systemic metabolic fitness and inflammatory activation of leukocytes.

2023-05-15

2024-02-27

2024-06-30

Recruiting

24

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).

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'daily time-restricted eating (TRE) protocol and a control protocol for each two weeks, separated by a four-week wash-out period', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Investigators analysing study outcomes will be blinde', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2023-06-12