Diet-induced ThermogenesisNCT07610759
Inter-Individual Variability in Early Diet-Induced Thermogenesis After a Standardized Meal
A study testing Standardized Liquid Meal in people with Diet-induced Thermogenesis, run by Tel Aviv University at 1 site in Israel.
Trial summary
This study aims to characterize how individuals differ in their metabolic response to food intake, specifically focusing on early diet-induced thermogenesis (DIT). DIT refers to the increase in energy expenditure that occurs after eating and reflects the body's metabolic response to processing nutrients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet-induced Thermogenesis
- What is being tested?
- Standardized Liquid Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2026to Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- Stable body weight (±2 kg over the previous 3 months)
- Generally healthy individuals
- Ability to comply with study procedures, including fasting and remaining at rest - during measurements
Who cannot join
- Use of medications known to affect metabolism (e.g., GLP-1 receptor agonists, systemic corticosteroids, uncontrolled thyroid disease)
- Insulin-treated diabetes
- Pregnancy or lactation
- Acute illness at the time of testing
- Inability to comply with pre-test requirements (e.g., fasting, avoiding caffeine, alcohol, or physical activity)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Inter-Individual Variability in Early Postprandial Thermogenesis Following a Standardized Liquid Meal
This study aims to characterize how individuals differ in their metabolic response to food intake, specifically focusing on early diet-induced thermogenesis (DIT). DIT refers to the increase in energy expenditure that occurs after eating and reflects the body's metabolic response to processing nutrients.
Healthy adult participants will complete a single laboratory visit under standardized conditions. Resting metabolic rate will first be measured, followed by consumption of a standardized liquid meal (550 kcal). Energy expenditure will then be continuously monitored for 3 hours using indirect calorimetry.
The primary objective is to quantify inter-individual variability in early postprandial thermogenesis. Rather than estimating total daily energy expenditure, this study focuses on the early metabolic response following meal ingestion. Findings will improve understanding of differences in metabolic efficiency between individuals and support future research in metabolism and personalized nutrition.
Read the detailed description
Diet-induced thermogenesis (DIT) represents the increase in energy expenditure above resting levels following food intake and reflects the energetic costs of digestion, absorption, transport, and metabolism of nutrients. Although DIT typically accounts for a relatively small proportion of total daily energy expenditure, it plays an important role in postprandial metabolism and may contribute to inter-individual differences in energy balance and body weight regulation.
Most prior research has focused on estimating total DIT over prolonged postprandial periods (e.g., 4-6 hours or longer). However, these approaches may obscure meaningful variability in the early phase of the thermogenic response, which is characterized by rapid and dynamic metabolic changes. The most pronounced increase in energy expenditure typically occurs within the first 1-3 hours following meal ingestion, driven by early physiological processes including gastrointestinal activity and neuroendocrine responses.
Emerging evidence suggests that individuals vary substantially in their metabolic response to a standardized meal, even under controlled conditions. However, this variability is often averaged out in group-level analyses or diluted by long measurement windows. The present study is specifically designed to characterize observed inter-individual variability in early DIT, rather than to estimate total thermogenesis or test intervention effects.
This study is a controlled, cross-sectional physiological study in healthy adults. Each participant will complete a single study visit under standardized laboratory conditions. After an initial resting period, resting metabolic rate will be measured using indirect calorimetry. Participants will then consume a standardized liquid meal providing 550 kcal, after which energy expenditure will be continuously monitored for 180 minutes.
Strict pre-test standardization procedures (including fasting, avoidance of exercise, caffeine, and alcohol) will be implemented to minimize non-biological variability. Body composition will also be assessed to support interpretation of metabolic responses.
The primary outcome is early DIT, quantified as the increase in energy expenditure above baseline over the postprandial period. Secondary analyses will describe the distribution, magnitude, and temporal characteristics of the thermogenic response, including peak response and time to peak.
By focusing on the early postprandial phase, this study aims to provide detailed characterization of variability in metabolic responses under tightly controlled conditions. These findings will contribute to a better understanding of human metabolic heterogeneity and may inform future research in metabolic physiology, obesity, and personalized nutrition.
Although a standardized liquid meal is administered as part of the protocol, the study is designed to characterize physiological variability in metabolic response rather than to evaluate the effect of an intervention.
- Conditions
- Diet-induced Thermogenesis
- Being tested
- Standardized Liquid Meal
- Keywords
- Diet-induced thermogenesis, Postprandial metabolism, Energy expenditure, Metabolic variability, Indirect calorimetry, Standardized meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Liquid MealOther
Also called Ensure®
Consumption of a standardized liquid meal (~550 kcal) under controlled laboratory conditions, followed by continuous measurement of energy expenditure using indirect calorimetry for assessment of postprandial thermogenesis. The procedure is used for measurement purposes only and is not intended as a therapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Participants | Experimental | Healthy adults (≥18 years) participating in a single laboratory visit. All participants undergo resting metabolic rate assessment, consume a standardized liquid meal (550 kcal), and complete continuous postprandial energy expenditure measurement using indirect calorimetry under controlled conditions. Receives: Other: Standardized Liquid Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Diet-Induced Thermogenesis Area Under the Curve
Area under the curve for diet-induced thermogenesis over 180 minutes after consumption of the standardized liquid meal. DIT will be calculated as postprandial energy expenditure minus baseline resting energy expenditure and expressed as kcal/180 min.
Measured: From meal completion to 180 minutes post-meal
Secondary outcomes (5)
Mean Diet-Induced Thermogenesis
Mean increase in energy expenditure above baseline resting energy expenditure during the 180-minute postprandial measurement period, expressed as kcal/min or kcal/180 min.
Measured: From meal completion to 180 minutes post-meal
Peak Diet-Induced Thermogenesis
Maximum increase in energy expenditure above baseline resting energy expenditure observed during the 180-minute postprandial measurement period, expressed as kcal/min.
Measured: From meal completion to 180 minutes post-meal
Time to Peak Diet-Induced Thermogenesis
From meal completion to 180 minutes post-meal
Measured: Time from completion of the standardized liquid meal to the maximum observed increase in energy expenditure, expressed in minutes.
Percent Increase in Energy Expenditure Above Baseline
Percentage increase in postprandial energy expenditure above baseline resting energy expenditure during the 180-minute measurement period.
Measured: From meal completion to 180 minutes post-meal
Fat-Free Mass-Normalized Diet-Induced Thermogenesis
Diet-induced thermogenesis area under the curve normalized to fat-free mass, expressed as kcal/180 min/kg fat-free mass.
Measured: From meal completion to 180 minutes post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet-induced ThermogenesisStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants undergo a single standardized protocol including baseline resting metabolic rate assessment, consumption of a standardized liquid meal, and continuous postprandial energy expenditure measurement under controlled laboratory conditions.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gepner Yftach, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610759
- Sponsor's protocol ID
- 0012144-1
- Status last verified
- Oct 2026
- First submitted
- 13 May 2026
- Last updated
- 8 Oct 2026
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-Individual Variability in Early Postprandial Thermogenesis Following a Standardized Liquid Meal
- ClinicalTrials.gov ID
- NCT07610759
- Acronym / sponsor ID
- 0012144-1
- Conditions
- Diet-induced Thermogenesis
- Keywords
- Diet-induced thermogenesis, Postprandial metabolism, Energy expenditure, Metabolic variability, Indirect calorimetry, Standardized meal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 May 2026 (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.
This study aims to characterize how individuals differ in their metabolic response to food intake, specifically focusing on early diet-induced thermogenesis (DIT). DIT refers to the increase in energy expenditure that occurs after eating and reflects the body's metabolic response to processing nutrients.
Healthy adult participants will complete a single laboratory visit under standardized conditions. Resting metabolic rate will first be measured, followed by consumption of a standardized liquid meal (550 kcal). Energy expenditure will then be continuously monitored for 3 hours using indirect calorimetry.
The primary objective is to quantify inter-individual variability in early postprandial thermogenesis. Rather than estimating total daily energy expenditure, this study focuses on the early metabolic response following meal ingestion. Findings will improve understanding of differences in metabolic efficiency between individuals and support future research in metabolism and personalized nutrition.
Detailed description
Diet-induced thermogenesis (DIT) represents the increase in energy expenditure above resting levels following food intake and reflects the energetic costs of digestion, absorption, transport, and metabolism of nutrients. Although DIT typically accounts for a relatively small proportion of total daily energy expenditure, it plays an important role in postprandial metabolism and may contribute to inter-individual differences in energy balance and body weight regulation.
Most prior research has focused on estimating total DIT over prolonged postprandial periods (e.g., 4-6 hours or longer). However, these approaches may obscure meaningful variability in the early phase of the thermogenic response, which is characterized by rapid and dynamic metabolic changes. The most pronounced increase in energy expenditure typically occurs within the first 1-3 hours following meal ingestion, driven by early physiological processes including gastrointestinal activity and neuroendocrine responses.
Emerging evidence suggests that individuals vary substantially in their metabolic response to a standardized meal, even under controlled conditions. However, this variability is often averaged out in group-level analyses or diluted by long measurement windows. The present study is specifically designed to characterize observed inter-individual variability in early DIT, rather than to estimate total thermogenesis or test intervention effects.
This study is a controlled, cross-sectional physiological study in healthy adults. Each participant will complete a single study visit under standardized laboratory conditions. After an initial resting period, resting metabolic rate will be measured using indirect calorimetry. Participants will then consume a standardized liquid meal providing 550 kcal, after which energy expenditure will be continuously monitored for 180 minutes.
Strict pre-test standardization procedures (including fasting, avoidance of exercise, caffeine, and alcohol) will be implemented to minimize non-biological variability. Body composition will also be assessed to support interpretation of metabolic responses.
The primary outcome is early DIT, quantified as the increase in energy expenditure above baseline over the postprandial period. Secondary analyses will describe the distribution, magnitude, and temporal characteristics of the thermogenic response, including peak response and time to peak.
By focusing on the early postprandial phase, this study aims to provide detailed characterization of variability in metabolic responses under tightly controlled conditions. These findings will contribute to a better understanding of human metabolic heterogeneity and may inform future research in metabolic physiology, obesity, and personalized nutrition.
Although a standardized liquid meal is administered as part of the protocol, the study is designed to characterize physiological variability in metabolic response rather than to evaluate the effect of an intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants undergo a single standardized protocol including baseline resting metabolic rate assessment, consumption of a standardized liquid meal, and continuous postprandial energy expenditure measurement under controlled laboratory conditions.
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Participants | Experimental | Other: Standardized Liquid MealHealthy adults (≥18 years) participating in a single laboratory visit. All participants undergo resting metabolic rate assessment, consume a standardized liquid meal (550 kcal), and complete continuous postprandial energy expenditure measurement using indirect calorimetry under controlled conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years
- Stable body weight (±2 kg over the previous 3 months)
- Generally healthy individuals
- Ability to comply with study procedures, including fasting and remaining at rest - during measurements
Key exclusion criteria (5 listed)
- Use of medications known to affect metabolism (e.g., GLP-1 receptor agonists, systemic corticosteroids, uncontrolled thyroid disease)
- Insulin-treated diabetes
- Pregnancy or lactation
- Acute illness at the time of testing
- Inability to comply with pre-test requirements (e.g., fasting, avoiding caffeine, alcohol, or physical activity)
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 |
|---|---|---|
| Standardized Liquid MealAlso: Ensure®Consumption of a standardized liquid meal (~550 kcal) under controlled laboratory conditions, followed by continuous measurement of energy expenditure using indirect calorimetry for assessment of postprandial thermogenesis. The procedure is used for measurement purposes only and is not intended as a therapeutic intervention. | Other | Healthy Adult Participants |
Primary outcome
Early Diet-Induced Thermogenesis Area Under the Curve
Time frame: From meal completion to 180 minutes post-meal
Area under the curve for diet-induced thermogenesis over 180 minutes after consumption of the standardized liquid meal. DIT will be calculated as postprandial energy expenditure minus baseline resting energy expenditure and expressed as kcal/180 min.
5 secondary outcomes
Mean Diet-Induced Thermogenesis
Time frame: From meal completion to 180 minutes post-meal
Peak Diet-Induced Thermogenesis
Time frame: From meal completion to 180 minutes post-meal
Time to Peak Diet-Induced Thermogenesis
Time frame: Time from completion of the standardized liquid meal to the maximum observed increase in energy expenditure, expressed in minutes.
Percent Increase in Energy Expenditure Above Baseline
Time frame: From meal completion to 180 minutes post-meal
Fat-Free Mass-Normalized Diet-Induced Thermogenesis
Time frame: From meal completion to 180 minutes post-meal
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 8 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Liquid Meal in people with Diet-induced Thermogenesis, run by Tel Aviv University at 1 site in Israel.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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 Israel. 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 Yftach Prof. Gepner (0506828501, gepner@tauex.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Diet-Induced Thermogenesis Area Under the Curve (time frame: From meal completion to 180 minutes post-meal). 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 8 Oct 2026.