Promoting Immune Health by Intermittent Fasting: a Pilot Study

HEALTHY VOLUNTEERS Clinical Trial

— TIGER  

Official title:

Promoting Immune Health by Intermittent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05898360
• Other study ID #: 2022.0697
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Max Nieuwdorp, MD PhD
• Phone: 0031 20 5669111
• Email: m.nieuwdorp[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 30, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Combination Product:
• Time Restricted Eating
time restricted eating

Other:
• normal diet
normal diet

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC location AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune health	measured by transcriptomic assays for immune phenotyping	0-2 weeks
Primary	inflammatory activation of leukocytes	measured by flow cytometry	0-2 weeks
Secondary	Changes in post-prandial bile acid metabolism	area under the curve of bile acid concentrations	2 hours
Secondary	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
Secondary	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
Secondary	The effect on energy expenditure	resting energy expenditure measured by indirect calorimetry during high fat meal test	2 hours
Secondary	The effect of Impaired fasting on gut microbiota composition.	measured at the end of the intervention by 16S sequencing	0-2 weeks
Secondary	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
Secondary	effect on appetie	visual scale scores (0(worst)-100%(best)) and quantity of food consumed	0-2 weeks