ObesityTREATNCT06061042
Effect of Timed-Restricted Eating on Metabolic Health
A study testing Early time restricted eating and Late time restricted eating in people with Obesity and Non-Alcoholic Fatty Liver Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
We aim to determine the effect of combined isocaloric time restricted eating and meal timing on metabolic health, liver fat, functional brain networks, inflammation, and sleep pattern/quality in subjects with obesity and insulin resistance. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Non-Alcoholic Fatty Liver Disease, Insulin Resistance
- What is being tested?
- Early time restricted eating and Late time restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent;
- BMI > 30kg/m^2;
- Insulin resistance, as defined by fasting plasma insulin > 62 pmol/L and/or prediabetes, as defined by fasting plasma glucose > 5.3 and < 7.0 mmol/L;
- Stable weight for 3 months prior to study inclusion
- For women, 1 year after last menstrual cycle
Who cannot join
- Use of any medication, except for those related to treatment of metabolic syndrome;
- Any medical condition interfering with study outcomes or design;
- History of any psychiatric disorder, including eating disorders;
- Performing shift work
- Performing intensive sports (>3 hours/week);
- Smoking;
Show all 11Show fewer
- Drugs abuse or alcohol abuse (>3 units/day);
- Contraindication for MRI;
- Known lactose/gluten intolerance;
- Known soy, egg, milk or peanut allergy;
- Childhood onset of obesity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah E Siegelaar, MD PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105AZ
Jur Kroon, BSc, +31 683238752, jur.kroon@amsterdamumc.nl
Jur Kroon, BSc
About this study
Official title: The Effect of Timed-Restricted Eating on Insulin Sensitivity, De Novo Lipogenesis and Liver Fat in Subjects With Obesity and Insulin Resistance
We aim to determine the effect of combined isocaloric time restricted eating and meal timing on metabolic health, liver fat, functional brain networks, inflammation, and sleep pattern/quality in subjects with obesity and insulin resistance.
Read the detailed description
Obesity is an alarming global health issue, with increasing prevalence. Obesity leads to a vast array of disorders, including dyslipidemia, the accumulation of intrahepatic triglycerides (IHTG), multiorgan insulin resistance and type 2 diabetes mellitus. In addition, disruption of the circadian rhythm (circadian misalignment), which is associated with irregular eating schedules, is an important risk factor for the development of obesity, IHTG and type 2 diabetes mellitus. Time restricted eating (TRE) is a form of intermittent fasting, in which the daily eating period is restricted. The beneficial effect of this type of diet might relate to adequate synchronization of food intake and fasting to the internal rhythm of the circadian tissue clocks, improving metabolic handling of nutrients and metabolic flexibility.
- Being tested
- Early time restricted eating, Late time restricted eating
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early time restricted eatingBehavioural
Also called early-TRE
Subjects will follow an isocaloric diet, designed by a dietician. The eating window for the early-TRE group is between 7 AM - 5 PM
Late time restricted eatingBehavioural
Also called late-TRE
Subjects will follow an isocaloric diet, designed by a dietician. The eating window for the late-TRE group is between 10 AM - 8 PM
| Study group | Role | What they receive |
|---|---|---|
| Early time-restricted eating | Experimental | * 50% of daily calories at breakfast, 35% at lunch and 15% at dinner. 85% of calories consumed in 6h, i.e., between 7AM and 1PM.
* Eating period, 10h (7AM-5PM); fasting period, 14h; Breakfast between 7 and 8 AM; lunch between 12 AM and 1 PM; dinner between 4 and 5 PM. Receives: Behavioral: Early time restricted eating |
| Late time-restricted eating | Experimental | * 15% of daily calories at breakfast, 35% at lunch and 50% at dinner. 85% of calories consumed in 6h, i.e., between 2PM and 8PM.
* Eating period, 10h (10AM-8PM), fasting period, 14h; Breakfast between 10 and 11 AM; lunch between 2 and 3 PM; dinner between 7 and 8 PM. Receives: Behavioral: Late time restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
We will use the Oral Minimal Model Method in conjunction with a Mixed Meal Tolerance Test (MMTT) to quantitatively evaluate insulin sensitivity. Concentrations of insulin, glucose, and C-peptide will be measured during the course of the MMTT to serve as the requisite inputs for the model. The output is in dl/kg/min/uU/ml.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Secondary outcomes (19)
Change in plasma insulin
Fasted and stimulated insulin (pmol/L) will be measured during MMTT
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Change in plasma glucose
Fasted and stimulated glucose (mmol/L) will be measured during MMTT
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Change in intrahepatic fat
To quantify the intrahepatic fat content, a single voxel 1H-MRS (magnetic resonance spectroscopy) will be used. Relative fat content will be expressed as the ratio of the fat peak over the cumulative fat and water peak. This will also be corrected for T2 relaxation.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Change in beta cell function (C-peptide)
Fasted and stimulated C-peptide (nmol/L) will be measured during MMTT
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Change in insulin aignaling
Biopsies will be taken from skeletal muscle and subcutaneous fat to measure key proteins in the insulin signalling pathway (Western blots)
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Change in glucose variability
In our study, we will deploy Continuous Glucose Monitors (CGMs) to acquire an in-depth understanding of glucose variability in participants throughout the course of the intervention. These monitors gauge glucose concentrations in the interstitial fluid (mmol/L), serving as a reliable proxy for blood glucose levels. This approach will enable us to assess key metrics such as mean, minimum and maximum glucose levels.
Measured: Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2
De novo lipogenesis
Fasted and stimulated de novo lipogenesis (DNL) will be measured during the MMT as 2H incorporation into fatty acids following deuterated water (2H2O) administration
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Immunological markers
We will conduct immune cell phenotyping on whole blood samples to identify and categorize various immune cell types. Additionally, we will assess immune cell function and metabolism in isolated peripheral blood mononuclear cells (PBMCs). Inflammatory markers will also be assessed in serum samples to provide a comprehensive overview of immune and inflammatory status.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Physical activity
Physical activity will be assessed via accelerometry. Accelerometry represents the magnitude of acceleration in any direction, over a predefined epoch.
Measured: Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2
Functional brain activity
Brain activation maps and functional connectivity will be assessed by blood oxygen dependent signals in the resting state and after visual food cues using functional magnetic resonance imaging (fMRI).
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Food Craving
We will use the General Food Cravings Questionnaire (G-FCQ) to evaluate the frequency and intensity of food cravings among participants. The scoring for the G-FCQ ranges between 21 and 105, with higher scores indicative of more pronounced food craving tendencies.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Eating behaviour
We will utilize the Dutch Eating Behavior Questionnaire (NVE) to assess and categorize the eating behaviors and tendencies of our participants. The NVE discerns three distinct eating styles: emotional eating, external eating, and restrained eating. A higher score within a specific style suggests a predominant inclination towards that particular eating behavior.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Hunger scale
We will employ a nine-question visual analogue scale (VAS) to assess hunger. Each question will be scored 0-100.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Food addiction
We will use the Yale Food Addiction Scale 2.0 (YFAS 2.0) to assess addictive behaviours. The YFAS 2.0 is designed in accordance with the DSM-5 criteria, and its scoring system mirrors the number of DSM-5 criteria fulfilled indicative of addiction.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Impulsiveness
We will use the Barratt Impulsiveness Scale (BIS) to scale impulsiveness towards food. This will help us understand how impulsivity might influence dietary behaviour. The score ranges from 30-120 and a higher score leans towards greater impulsivity.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Chronotype
To determine natural sleep-wake patterns, we will use the Munich Chronotype Questionnaire (MCTQ). This tool offers a comprehensive understanding of sleep behaviors, revealing a chronotype.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Subject experience with intervention
We will employ a semi-structured oral interview as part of our qualitative approach to understand our participants' experience and adherence to the intervention.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Delay discounting computational task
The delay discounting task aids in understanding the decision-making processes that might contribute to overeating and poor food choices. In this task, we will be able to measure the ability of each individual to delay immediate gratification for a greater future reward.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Iowa gambling computational task
We use the Iowa gambling task to assess decision-making and risk-reward sensitivity. Participants choose cards from four decks, each with different reward and punishment rates, aiming to maximize their winnings. We use this task to study risk taking and impulsive behaviour.
Measured: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetesfonds
- Responsible party
- Principal investigator, Prof. Dr. Mireille JM Serlie, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Mireille JM Serlie, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061042
- Sponsor's protocol ID
- NL79197.018.21
- Acronym
- TREAT
- Status last verified
- Feb 2023
- First submitted
- 24 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Timed-Restricted Eating on Insulin Sensitivity, De Novo Lipogenesis and Liver Fat in Subjects With Obesity and Insulin Resistance
- ClinicalTrials.gov ID
- NCT06061042
- Acronym / sponsor ID
- TREAT / NL79197.018.21
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Diabetesfonds
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Sep 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.
We aim to determine the effect of combined isocaloric time restricted eating and meal timing on metabolic health, liver fat, functional brain networks, inflammation, and sleep pattern/quality in subjects with obesity and insulin resistance.
Detailed description
Obesity is an alarming global health issue, with increasing prevalence. Obesity leads to a vast array of disorders, including dyslipidemia, the accumulation of intrahepatic triglycerides (IHTG), multiorgan insulin resistance and type 2 diabetes mellitus. In addition, disruption of the circadian rhythm (circadian misalignment), which is associated with irregular eating schedules, is an important risk factor for the development of obesity, IHTG and type 2 diabetes mellitus. Time restricted eating (TRE) is a form of intermittent fasting, in which the daily eating period is restricted. The beneficial effect of this type of diet might relate to adequate synchronization of food intake and fasting to the internal rhythm of the circadian tissue clocks, improving metabolic handling of nutrients and metabolic flexibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early time-restricted eating | Experimental | Behavioral: Early time restricted eating* 50% of daily calories at breakfast, 35% at lunch and 15% at dinner. 85% of calories consumed in 6h, i.e., between 7AM and 1PM. * Eating period, 10h (7AM-5PM); fasting period, 14h; Breakfast between 7 and 8 AM; lunch between 12 AM and 1 PM; dinner between 4 and 5 PM. |
| Late time-restricted eating | Experimental | Behavioral: Late time restricted eating* 15% of daily calories at breakfast, 35% at lunch and 50% at dinner. 85% of calories consumed in 6h, i.e., between 2PM and 8PM. * Eating period, 10h (10AM-8PM), fasting period, 14h; Breakfast between 10 and 11 AM; lunch between 2 and 3 PM; dinner between 7 and 8 PM. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide informed consent;
- BMI > 30kg/m^2;
- Insulin resistance, as defined by fasting plasma insulin > 62 pmol/L and/or prediabetes, as defined by fasting plasma glucose > 5.3 and < 7.0 mmol/L;
- Stable weight for 3 months prior to study inclusion
- For women, 1 year after last menstrual cycle
Key exclusion criteria (11 listed)
- Use of any medication, except for those related to treatment of metabolic syndrome;
- Any medical condition interfering with study outcomes or design;
- History of any psychiatric disorder, including eating disorders;
- Performing shift work
- Performing intensive sports (>3 hours/week);
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 |
|---|---|---|
| Early time restricted eatingAlso: early-TRESubjects will follow an isocaloric diet, designed by a dietician. The eating window for the early-TRE group is between 7 AM - 5 PM | Behavioural | Early time-restricted eating |
| Late time restricted eatingAlso: late-TRESubjects will follow an isocaloric diet, designed by a dietician. The eating window for the late-TRE group is between 10 AM - 8 PM | Behavioural | Late time-restricted eating |
Primary outcome
Insulin Sensitivity
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
We will use the Oral Minimal Model Method in conjunction with a Mixed Meal Tolerance Test (MMTT) to quantitatively evaluate insulin sensitivity. Concentrations of insulin, glucose, and C-peptide will be measured during the course of the MMTT to serve as the requisite inputs for the model. The output is in dl/kg/min/uU/ml.
19 secondary outcomes
Change in plasma insulin
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Change in plasma glucose
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Change in intrahepatic fat
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Change in beta cell function (C-peptide)
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Change in insulin aignaling
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Change in glucose variability
Time frame: Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2
De novo lipogenesis
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Immunological markers
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Physical activity
Time frame: Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2
Functional brain activity
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Food Craving
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Eating behaviour
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Hunger scale
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Food addiction
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Impulsiveness
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Psychological factor - Chronotype
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Subject experience with intervention
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Delay discounting computational task
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Iowa gambling computational task
Time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 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.
Sarah E Siegelaar, MD PhD contact
Mireille JM Serlie, 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 Early time restricted eating and Late time restricted eating in people with Obesity and Non-Alcoholic Fatty Liver Disease, 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 29 Sep 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jur Kroon, BSc (+31 683238752, jur.kroon@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2). 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 29 Sep 2023.