Promoting Immune Health by Intermittent Fasting: a Pilot Study

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome; HEALTHY VOLUNTEERS; Insulin Resistance; Time Restricted Feeding; Inflammation
• Interventions: Combination Product: Time Restricted Eating; Other: normal diet

• Registration Number: NCT05898360
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study First Submitted: 2023-02-12
• Study Start: 2023-05-15
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-01
• Last Update Submitted: 2023-06-01
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-12
• Primary Completion: 2024-02-27
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
daily time-restricted eating (TRE) for 2 weeks	Time Restricted Eating	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
control protocol for each two weeks	normal diet	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

Primary Outcome Measures

Name	Time	Method
inflammatory activation of leukocytes	0-2 weeks	measured by flow cytometry
Immune health	0-2 weeks	measured by transcriptomic assays for immune phenotyping

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Amsterdam UMC location AMC; 🇳🇱 Amsterdam, Netherlands