Promoting Immune Health by Intermittent Fasting: a Pilot Study

NCT ID: NCT05898360

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2024-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Time Restricted Eating

Intervention Type: COMBINATION_PRODUCT

time restricted eating

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

Group Type: PLACEBO_COMPARATOR

normal diet

Intervention Type: OTHER

normal diet

Interventions

Time Restricted Eating

time restricted eating

Intervention Type: COMBINATION_PRODUCT

normal diet

normal diet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Max Nieuwdorp

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maarten R Soeters, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Amsterdam UMC location AMC

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Max Nieuwdorp, MD PhD

Role: CONTACT

m.nieuwdorp@amsterdamumc.nl

0031 20 5669111

Maarten R Soeters, MD PhD

Role: CONTACT

m.r.soeters@amsterdamumc.nl

0031205666071

Facility Contacts

max nieuwdorp, MD PhD

Role: primary

m.nieuwdorp@amsterdamumc.nl

0031 20 5669111

Other Identifiers

2022.0697

Identifier Type: -

Identifier Source: org_study_id