Promoting Immune Health by Intermittent Fasting: a Pilot Study (TIGER)

Promoting Immune Health by Intermittent

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Metabolic Syndrome; Insulin Resistance; Time Restricted Feeding; HEALTHY VOLUNTEERS
• Intervention / Treatment: Other: normal diet; Combination product: Time Restricted Eating

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: max nieuwdorp, MD PhD; Phone Number: 0031 20 5669111; Email: m.nieuwdorp@amsterdamumc.nl
• Study Contact Backup: Name: Maarten R Soeters, MD PhD; Phone Number: 0031205666071; Email: m.r.soeters@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC location AMC
    • Contact: max nieuwdorp, MD PhD; Phone Number: 0031 20 5669111; Email: m.nieuwdorp@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: daily time-restricted eating (TRE) for 2 weeks; 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; time restricted eating
Placebo Comparator: control protocol for each two weeks; 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; normal diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune health	measured by transcriptomic assays for immune phenotyping	0-2 weeks
inflammatory activation of leukocytes	measured by flow cytometry	0-2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in post-prandial bile acid metabolism	area under the curve of bile acid concentrations	2 hours
The effect of IF on glucose tolerance	measured during high fat meal test as well during the inverention (by FSL)	2 hours and 0-2 weeks
The effect of IF on the transcriptional and epigenetic repertoire of whole blood monocytes by stimulation assays	the effect on the inflammatory status	0-2 weeks
The effect on energy expenditure	resting energy expenditure measured by indirect calorimetry during high fat meal test	2 hours
The effect of Impaired fasting on gut microbiota composition.	measured at the end of the intervention by 16S sequencing	0-2 weeks
Effect on Body composition and Appetite (visual analog scale scores + quantity of food consumed)	measured during high fat meal test in terms of fat mass(kg) and fat free mass (kg)	0-2 weeks
effect on appetie	visual scale scores (0(worst)-100%(best)) and quantity of food consumed	0-2 weeks

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Maarten R Soeters, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): February 27, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Inflammation; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: 2022.0697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No