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

Primary Purpose

Metabolic Syndrome, HEALTHY VOLUNTEERS, Time Restricted Feeding

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Time Restricted Eating
normal diet
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Syndrome

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Amsterdam UMC location AMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

daily time-restricted eating (TRE) for 2 weeks

control protocol for each two weeks

Arm 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

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

Outcomes

Primary Outcome Measures

Immune health
measured by transcriptomic assays for immune phenotyping
inflammatory activation of leukocytes
measured by flow cytometry

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2023
Last Updated
June 1, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT05898360
Brief Title
Promoting Immune Health by Intermittent Fasting: a Pilot Study
Acronym
TIGER
Official Title
Promoting Immune Health by Intermittent
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
February 27, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, HEALTHY VOLUNTEERS, Time Restricted Feeding, Insulin Resistance, Inflammation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
daily time-restricted eating (TRE) protocol and a control protocol for each two weeks, separated by a four-week wash-out period
Masking
Outcomes Assessor
Masking Description
Investigators analysing study outcomes will be blinde
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
daily time-restricted eating (TRE) for 2 weeks
Arm Type
Experimental
Arm 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
Arm Title
control protocol for each two weeks
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Combination Product
Intervention Name(s)
Time Restricted Eating
Intervention Description
time restricted eating
Intervention Type
Other
Intervention Name(s)
normal diet
Intervention Description
normal diet
Primary Outcome Measure Information:
Title
Immune health
Description
measured by transcriptomic assays for immune phenotyping
Time Frame
0-2 weeks
Title
inflammatory activation of leukocytes
Description
measured by flow cytometry
Time Frame
0-2 weeks
Secondary Outcome Measure Information:
Title
Changes in post-prandial bile acid metabolism
Description
area under the curve of bile acid concentrations
Time Frame
2 hours
Title
The effect of IF on glucose tolerance
Description
measured during high fat meal test as well during the inverention (by FSL)
Time Frame
2 hours and 0-2 weeks
Title
The effect of IF on the transcriptional and epigenetic repertoire of whole blood monocytes by stimulation assays
Description
the effect on the inflammatory status
Time Frame
0-2 weeks
Title
The effect on energy expenditure
Description
resting energy expenditure measured by indirect calorimetry during high fat meal test
Time Frame
2 hours
Title
The effect of Impaired fasting on gut microbiota composition.
Description
measured at the end of the intervention by 16S sequencing
Time Frame
0-2 weeks
Title
Effect on Body composition and Appetite (visual analog scale scores + quantity of food consumed)
Description
measured during high fat meal test in terms of fat mass(kg) and fat free mass (kg)
Time Frame
0-2 weeks
Title
effect on appetie
Description
visual scale scores (0(worst)-100%(best)) and quantity of food consumed
Time Frame
0-2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Max Nieuwdorp, MD PhD
Phone
0031 20 5669111
Email
m.nieuwdorp@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Maarten R Soeters, MD PhD
Phone
0031205666071
Email
m.r.soeters@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten R Soeters, MD PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC location AMC
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
max nieuwdorp, MD PhD
Phone
0031 20 5669111
Email
m.nieuwdorp@amsterdamumc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Promoting Immune Health by Intermittent Fasting: a Pilot Study

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