Clinical trial NCT05898360: Promoting Immune Health by Intermittent Fasting: a Pilot Study
Official title: Promoting Immune Health by Intermittent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
HEALTHY VOLUNTEERS
Time Restricted Feeding
Insulin Resistance
Inflammation
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Immune health
timeFrame: 0-2 weeks
measure: inflammatory activation of leukocytes
timeFrame: 0-2 weeks
Secondary outcomes:
measure: Changes in post-prandial bile acid metabolism
timeFrame: 2 hours
measure: The effect of IF on glucose tolerance
timeFrame: 2 hours and 0-2 weeks
measure: The effect of IF on the transcriptional and epigenetic repertoire of whole blood monocytes by stimulation assays
timeFrame: 0-2 weeks
measure: The effect on energy expenditure
timeFrame: 2 hours
measure: The effect of Impaired fasting on gut microbiota composition.
timeFrame: 0-2 weeks
measure: Effect on Body composition and Appetite (visual analog scale scores + quantity of food consumed)
timeFrame: 0-2 weeks
measure: effect on appetie
timeFrame: 0-2 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location AMC
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Maarten R Soeters, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: