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

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

Status: Enrolling

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

Treatments: Combination Product: Time Restricted Eating; Other: normal diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05898360

2022.0697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

daily time-restricted eating (TRE) for 2 weeks

Experimental group

Description:

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

Treatment:

Combination Product: Time Restricted Eating

control protocol for each two weeks

Placebo Comparator group

Description:

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

Treatment:

Other: normal diet