Phase
Condition
Inflammation
Hormone Deficiencies
Metabolic Syndrome
Treatment
normal diet
Time Restricted Eating
Clinical Study ID
Ages 21-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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).
Study Design
Study Description
Connect with a study center
Amsterdam UMC location AMC
Amsterdam,
NetherlandsActive - Recruiting
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