Effects of Intermittent Fasting on Immune Health

Promoting Immune Health by Intermittent

This study is testing how long-term intermittent fasting affects immune health and metabolism in people with metabolic syndrome and healthy individuals.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Amsterdam)
• Trial ID: NCT05898360 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the impact of long-term intermittent fasting on immune cell populations and metabolic fitness in individuals with metabolic syndrome and healthy volunteers. The researchers will analyze the molecular characteristics of monocytes and their health benefits, focusing on post-prandial inflammation and monocyte activation. By understanding the mechanisms behind intermittent fasting, the study aims to personalize lifestyle guidance and identify new anti-inflammatory processes that influence immune responses.

Who should consider this trial

Good fit: Ideal candidates include individuals with metabolic syndrome and healthy volunteers who meet specific BMI and HOMA-IR criteria.

Not a fit: Patients who have experienced significant weight loss recently or have certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved immune health and metabolic fitness through dietary interventions.

How similar studies have performed: Other studies have shown promising results with intermittent fasting, suggesting potential benefits in metabolic health 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).

Where this trial is running

Amsterdam

• Amsterdam UMC location AMC — Amsterdam, Netherlands (Recruiting)

Study contacts

• Principal investigator: Maarten R Soeters, MD PhD — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Study coordinator: Max Nieuwdorp, MD PhD

Conditions Metabolic Syndrome; HEALTHY VOLUNTEERS; Time Restricted Feeding; Insulin Resistance; Inflammation