HEALTHY VOLUNTEERS, Inflammation, Insulin Resistance, Metabolic Syndrome, Time Restricted Feeding
Conditions
Brief summary
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.
Detailed description
the investigators aim to investigate the direct effects of intermittent fasting on the molecular characteristics of monocytes and their related health benefits. In addition,the investigators want to assess the post-prandial inflammation and the potential protective role of IF on post-prandial monocyte activation and its related health benefits. This pilot study may better understand the molecular mechanisms behind IF, which could further personalize lifestyle guidance and identify novel anti-inflammatory processes that control immune responses and inflammation.
Interventions
COMBINATION_PRODUCTTime Restricted Eating
time restricted eating
OTHERnormal diet
normal diet
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Investigators analysing study outcomes will be blinde
Intervention model description
daily time-restricted eating (TRE) protocol and a control protocol for each two weeks, separated by a four-week wash-out period
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune health | 0-2 weeks | measured by transcriptomic assays for immune phenotyping |
| inflammatory activation of leukocytes | 0-2 weeks | measured by flow cytometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of IF on the transcriptional and epigenetic repertoire of whole blood monocytes by stimulation assays | 0-2 weeks | the effect on the inflammatory status |
| The effect on energy expenditure | 2 hours | resting energy expenditure measured by indirect calorimetry during high fat meal test |
| Changes in post-prandial bile acid metabolism | 2 hours | area under the curve of bile acid concentrations |
| Effect on Body composition and Appetite (visual analog scale scores + quantity of food consumed) | 0-2 weeks | measured during high fat meal test in terms of fat mass(kg) and fat free mass (kg) |
| effect on appetie | 0-2 weeks | visual scale scores (0(worst)-100%(best)) and quantity of food consumed |
| The effect of Impaired fasting on gut microbiota composition. | 0-2 weeks | measured at the end of the intervention by 16S sequencing |
| The effect of IF on glucose tolerance | 2 hours and 0-2 weeks | measured during high fat meal test as well during the inverention (by FSL) |
Countries
Netherlands
Contacts
Primary ContactMax Nieuwdorp, MD PhD
Backup ContactMaarten R Soeters, MD PhD
Outcome results
None listed