Promoting Immune Health by Intermittent Fasting: a Pilot Study

NCT05898360 | Unknown

• 1 other identifier: 2022.0697
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Immune health

  measured by transcriptomic assays for immune phenotyping

  0-2 weeks

• inflammatory activation of leukocytes

  measured by flow cytometry

  0-2 weeks

Secondary Outcomes (7)

• Changes in post-prandial bile acid metabolism

  2 hours

• The effect of IF on glucose tolerance

  2 hours and 0-2 weeks

• The effect of IF on the transcriptional and epigenetic repertoire of whole blood monocytes by stimulation assays

  0-2 weeks

• The effect on energy expenditure

  2 hours

• The effect of Impaired fasting on gut microbiota composition.

  0-2 weeks

Study Arms (2)

daily time-restricted eating (TRE) for 2 weeks

EXPERIMENTAL

Subjects will be instructed to consume all calories needed for a stable weight (based on their resting energy expenditure) in either one meal per day (TRE; between 10:00-11:00; a protein snack at 13 h) or in three meals per day (control; breakfast, lunch and dinner). Prior to the intervention, a dietician will instruct subjects on nutritional intake based on their caloric need measured by indirect calorimetry (see indirect calorimetry). During the intervention, subjects will fill in online or written dietary diary (e.g. eetmeter) and a physical activity diary. Halfway the intervention, a telephone consult with a dietician will take place

Combination Product: Time Restricted Eating

control protocol for each two weeks

PLACEBO COMPARATOR

Subjects will be instructed to consume normal diet/calories. Prior to the intervention, a dietician will instruct subjects on nutritional intake based on their caloric need measured by indirect calorimetry (see indirect calorimetry). During the intervention, subjects will fill in online or written dietary diary (e.g. eetmeter) and a physical activity diary. Halfway the intervention, a telephone consult with a dietician will take place

Other: normal diet

Interventions

Time Restricted Eating COMBINATION_PRODUCT

time restricted eating

daily time-restricted eating (TRE) for 2 weeks

normal diet OTHER

normal diet

control protocol for each two weeks

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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)

You may not qualify if:

• 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;
• Irregular menstrual cycle;
• Hormonal replacement therapy (other than oral contraceptives).

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC location AMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Intermittent Fasting; Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fasting; Feeding Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maarten R Soeters, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Nieuwdorp, MD PhD

CONTACT

0031 20 5669111; m.nieuwdorp@amsterdamumc.nl

Maarten R Soeters, MD PhD

CONTACT

0031205666071; m.r.soeters@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators analysing study outcomes will be blinde
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: daily time-restricted eating (TRE) protocol and a control protocol for each two weeks, separated by a four-week wash-out period

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: June 12, 2023
• Study Start: May 15, 2023
• Primary Completion: February 27, 2024
• Study Completion: June 30, 2024
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)