Promoting Immune Health by Intermittent Fasting: a Pilot Study

Last updated: June 1, 2023
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Hormone Deficiencies

Metabolic Syndrome

Treatment

normal diet

Time Restricted Eating

Clinical Study ID

NCT05898360
2022.0697
  • Ages 21-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

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

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: normal diet
Phase:
Study Start date:
May 15, 2023
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Amsterdam UMC location AMC

    Amsterdam,
    Netherlands

    Active - Recruiting

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