Metabolic SyndromeTIGERNCT05898360
Promoting Immune Health by Intermittent Fasting: a Pilot Study
A study testing Time Restricted Eating and normal diet in people with Metabolic Syndrome and HEALTHY VOLUNTEERS, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, HEALTHY VOLUNTEERS, Time Restricted Feeding
- What is being tested?
- Time Restricted Eating and normal diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 May 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- HDL-cholesterol<1.04mmol/l,
- Bloodpressure≥130/85mmHg).
- 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)
Who cannot join
- 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);
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- 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 locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC location AMC
Amsterdam
max nieuwdorp, MD PhD, 0031 20 5669111, m.nieuwdorp@amsterdamumc.nl
About this study
Official title: Promoting Immune Health by Intermittent
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.
Read the 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
- Being tested
- Time Restricted Eating, normal diet
- Medical subject headings
- Metabolic Syndrome, Intermittent Fasting, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingCombination product
time restricted eating
normal dietOther
normal diet
| Study group | Role | What they receive |
|---|---|---|
| daily time-restricted eating (TRE) for 2 weeks | Experimental | 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 Receives: Combination Product: Time Restricted Eating |
| control protocol for each two weeks | Placebo comparator | 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 Receives: Other: normal diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune health
measured by transcriptomic assays for immune phenotyping
Measured: 0-2 weeks
inflammatory activation of leukocytes
measured by flow cytometry
Measured: 0-2 weeks
Secondary outcomes (7)
Changes in post-prandial bile acid metabolism
area under the curve of bile acid concentrations
Measured: 2 hours
The effect of IF on glucose tolerance
measured during high fat meal test as well during the inverention (by FSL)
Measured: 2 hours and 0-2 weeks
The effect of IF on the transcriptional and epigenetic repertoire of whole blood monocytes by stimulation assays
the effect on the inflammatory status
Measured: 0-2 weeks
The effect on energy expenditure
resting energy expenditure measured by indirect calorimetry during high fat meal test
Measured: 2 hours
The effect of Impaired fasting on gut microbiota composition.
measured at the end of the intervention by 16S sequencing
Measured: 0-2 weeks
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)
Measured: 0-2 weeks
effect on appetie
visual scale scores (0(worst)-100%(best)) and quantity of food consumed
Measured: 0-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start15 May 2023
- Primary completion27 Feb 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Nieuwdorp, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Maarten R Soeters, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898360
- Sponsor's protocol ID
- 2022.0697
- Acronym
- TIGER
- Status last verified
- Jun 2023
- First submitted
- 12 Feb 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Immune Health by Intermittent
- ClinicalTrials.gov ID
- NCT05898360
- Acronym / sponsor ID
- TIGER / 2022.0697
- Conditions
- Metabolic Syndrome, HEALTHY VOLUNTEERS, Time Restricted Feeding, Insulin Resistance, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 27 Feb 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- daily time-restricted eating (TRE) protocol and a control protocol for each two weeks, separated by a four-week wash-out period
| Arm | Type | Receives |
|---|---|---|
| daily time-restricted eating (TRE) for 2 weeks | Experimental | Combination Product: Time Restricted EatingSubjects 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 | Placebo comparator | Other: normal dietSubjects 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 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted Eatingtime restricted eating | Combination product | daily time-restricted eating (TRE) for 2 weeks |
| normal dietnormal diet | Other | control protocol for each two weeks |
Primary outcome
Immune health
Time frame: 0-2 weeks
measured by transcriptomic assays for immune phenotyping
inflammatory activation of leukocytes
Time frame: 0-2 weeks
measured by flow cytometry
7 secondary outcomes
Changes in post-prandial bile acid metabolism
Time frame: 2 hours
The effect of IF on glucose tolerance
Time frame: 2 hours and 0-2 weeks
The effect of IF on the transcriptional and epigenetic repertoire of whole blood monocytes by stimulation assays
Time frame: 0-2 weeks
The effect on energy expenditure
Time frame: 2 hours
The effect of Impaired fasting on gut microbiota composition.
Time frame: 0-2 weeks
Effect on Body composition and Appetite (visual analog scale scores + quantity of food consumed)
Time frame: 0-2 weeks
effect on appetie
Time frame: 0-2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten R Soeters, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating and normal diet in people with Metabolic Syndrome and HEALTHY VOLUNTEERS, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Max Nieuwdorp, MD PhD (0031 20 5669111, m.nieuwdorp@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune health (time frame: 0-2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.