PathophysiologyGLIPIDNCT07557628
Study of the Hypothalamic Microglial Response as a Function of a Meal's Lipid Content in Humans. A Single-center Prospective Cohort Study in Healthy Male Subjects
An observational study of Pathophysiology, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Obesity and its complications represent a growing public health problem in our society. A better understanding of the biological mechanisms involved in regulating food intake-and, more broadly, energy metabolism-should lead to improved management of this condition. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pathophysiology
- What is being tested?
- Blood sample, Brain MRI without contrast, performed on an empty stomach and after a meal and Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2026to Sep 2028
- Phase
- Observational
- 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 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy male volunteers
Who may be able to join
- A person who has given oral consent
- Male
- Body Mass Index (BMI) between 18.5 and 30 kg/m²
- Age ≥ 20 years
Who cannot join
- A person subject to a measure of legal protection (guardianship, tutorship)
- A person subject to a judicial protective measure
- A person who is not enrolled in or eligible for a social security program
- Subject does not speak French
- Subjects with a pacemaker or any other contraindication to MRI
- Subjects with type 1 or type 2 diabetes
Show all 10Show fewer
- Subjects with a chronic inflammatory condition
- Subjects with a neuropsychiatric condition
- Subjects taking anti-inflammatory medication or medication that affects the central nervous system
- Known hypersensitivity to foods provided during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Vincent SCHNEIDER, 03 80 29 30 89 ext. +33, vincent.schneider@chu-dijon.fr
About this study
Obesity and its complications represent a growing public health problem in our society. A better understanding of the biological mechanisms involved in regulating food intake-and, more broadly, energy metabolism-should lead to improved management of this condition.
Recent studies have shown that eating a single meal can rapidly trigger the activation of the immune system. This leads to a postprandial, systemic, and transient inflammatory response (Emerson SR, Adv Nutr 2017). It is found in both healthy and obese individuals. It has also been observed in rodents, enabling preclinical studies to better understand the phenomenon. This postprandial inflammation is characterized by the activation of macrophages in the gastrointestinal tract and by elevated levels of circulating pro-inflammatory markers. At the cellular level, nutrients activate an intracellular molecular sensor called the inflammasome, which is a multiprotein complex formed by the oligomerization of proteins including NLRP3 (Nod-like receptors pyrin domain-containing 3) and ASC (Apoptosis-associated Speck-like protein containing a CARD domain). This sensor activates caspase 1, an enzyme that converts pro-interleukin 1β (pro-IL-1β) into its mature and active form, IL-1β. This molecular mechanism converts the nutritional signal into an immune response.
Read more
Under physiological conditions, this acute response appears to have beneficial effects on the body. Indeed, it plays a positive role in blood glucose control by stimulating insulin secretion and glucose utilization (Dror, Nat Immunol 2017). However, in the context of chronic overeating and excessive consumption of saturated fats and simple sugars, this systemic inflammation becomes harmful, promoting adipocyte hypertrophy, insulin resistance, hepatic steatosis, and vascular damage (Hotamisligil, Nature 2017).
In mice, our team recently demonstrated the existence of a postprandial inflammatory response in the central nervous system (Cansell, Glia 2021). This response occurs specifically in the hypothalamus, a brain structure involved in regulating food intake and controlling energy metabolism. It is characterized by microglial reactivity visible as early as 3 hours after the start of the postprandial phase. This postprandial microglial activation occurs after the ingestion of a high-fat meal, whereas it is rarely or never observed after the ingestion of a standard balanced meal. It is characterized by a morphological change in hypothalamic microglia, including an increase in the length of microglial processes and their branching. This gliosis is associated with increased expression of IL-1β in microglial cells. Thus, the postprandial gliosis observed 3 hours after a high-fat meal is inflammatory. Using a targeted genetic approach that allows for the ablation of the inflammasome in microglial cells, the team demonstrates that postprandial gliosis exerts a satiating effect, limiting subsequent food intake following a high-calorie, high-fat meal. Thus, microglial inflammation appears to be an additional component in the body's arsenal of adaptive homeostatic responses aimed at limiting energy intake.
Our clinical project will involve translating our basic findings in mice to humans. This will involve investigating postprandial hypothalamic gliosis in the human brain following a standard meal or a high-fat meal. The initial studies will be conducted exclusively in healthy male subjects to avoid the influence of the hormonal cycle on the hypothalamic response. The impact of physiological aging on the hypothalamic microglial inflammatory response will also be taken into account.
- Conditions
- Pathophysiology
- Being tested
- Blood sample, Brain MRI without contrast, performed on an empty stomach and after a meal, Questionnaires, Bioelectrical impedance analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Hormone and metabolic tests (insulin, IGF-1, leptin, blood glucose, ghrelin)
Brain MRI without contrast, performed on an empty stomach and after a mealProcedure or surgery
Measurement of the T1 and T2 relaxation times in the hypothalamic region
QuestionnairesOther
Eating habits and preferences
Bioelectrical impedance analysisOther
Measurements of lean body mass, fat mass, body water and bone mass
| Study group | Role | What they receive |
|---|---|---|
| Male subjects | Healthy volunteers to study the biological mechanisms that control food intake and energy metabolism Receives: Biological: Blood sample; Procedure: Brain MRI without contrast, performed on an empty stomach and after a meal; Other: Questionnaires; Other: Bioelectrical impedance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in hypothalamic MRI signal intensity between the baseline state and the postprandial state observed after a balanced meal and after a high-fat meal for each subject.
Measurement of hypothalamic T2 relaxation time
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start5 Sep 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PathophysiologyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557628
- Sponsor's protocol ID
- SCHNEIDER 2025
- Acronym
- GLIPID
- Status last verified
- Sep 2026
- First submitted
- 22 Apr 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Hypothalamic Microglial Response as a Function of a Meal's Lipid Content in Humans. A Single-center Prospective Cohort Study in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT07557628
- Acronym / sponsor ID
- GLIPID / SCHNEIDER 2025
- Conditions
- Pathophysiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 5 Sep 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 Apr 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.
Obesity and its complications represent a growing public health problem in our society. A better understanding of the biological mechanisms involved in regulating food intake-and, more broadly, energy metabolism-should lead to improved management of this condition.
Recent studies have shown that eating a single meal can rapidly trigger the activation of the immune system. This leads to a postprandial, systemic, and transient inflammatory response (Emerson SR, Adv Nutr 2017). It is found in both healthy and obese individuals. It has also been observed in rodents, enabling preclinical studies to better understand the phenomenon. This postprandial inflammation is characterized by the activation of macrophages in the gastrointestinal tract and by elevated levels of circulating pro-inflammatory markers. At the cellular level, nutrients activate an intracellular molecular sensor called the inflammasome, which is a multiprotein complex formed by the oligomerization of proteins including NLRP3 (Nod-like receptors pyrin domain-containing 3) and ASC (Apoptosis-associated Speck-like protein containing a CARD domain). This sensor activates caspase 1, an enzyme that converts pro-interleukin 1β (pro-IL-1β) into its mature and active form, IL-1β. This molecular mechanism converts the nutritional signal into an immune response.
Under physiological conditions, this acute response appears to have beneficial effects on the body. Indeed, it plays a positive role in blood glucose control by stimulating insulin secretion and glucose utilization (Dror, Nat Immunol 2017). However, in the context of chronic overeating and excessive consumption of saturated fats and simple sugars, this systemic inflammation becomes harmful, promoting adipocyte hypertrophy, insulin resistance, hepatic steatosis, and vascular damage (Hotamisligil, Nature 2017).
In mice, our team recently demonstrated the existence of a postprandial inflammatory response in the central nervous system (Cansell, Glia 2021). This response occurs specifically in the hypothalamus, a brain structure involved in regulating food intake and controlling energy metabolism. It is characterized by microglial reactivity visible as early as 3 hours after the start of the postprandial phase. This postprandial microglial activation occurs after the ingestion of a high-fat meal, whereas it is rarely or never observed after the ingestion of a standard balanced meal. It is characterized by a morphological change in hypothalamic microglia, including an increase in the length of microglial processes and their branching. This gliosis is associated with increased expression of IL-1β in microglial cells. Thus, the postprandial gliosis observed 3 hours after a high-fat meal is inflammatory. Using a targeted genetic approach that allows for the ablation of the inflammasome in microglial cells, the team demonstrates that postprandial gliosis exerts a satiating effect, limiting subsequent food intake following a high-calorie, high-fat meal. Thus, microglial inflammation appears to be an additional component in the body's arsenal of adaptive homeostatic responses aimed at limiting energy intake.
Our clinical project will involve translating our basic findings in mice to humans. This will involve investigating postprandial hypothalamic gliosis in the human brain following a standard meal or a high-fat meal. The initial studies will be conducted exclusively in healthy male subjects to avoid the influence of the hormonal cycle on the hypothalamic response. The impact of physiological aging on the hypothalamic microglial inflammatory response will also be taken into account.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male subjects | – | Biological: Blood sample, Procedure: Brain MRI without contrast, performed on an empty stomach and after a meal, Other: Questionnaires, Other: Bioelectrical impedance analysisHealthy volunteers to study the biological mechanisms that control food intake and energy metabolism |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy male volunteers
Key inclusion criteria (4 listed)
- A person who has given oral consent
- Male
- Body Mass Index (BMI) between 18.5 and 30 kg/m²
- Age ≥ 20 years
Key exclusion criteria (10 listed)
- A person subject to a measure of legal protection (guardianship, tutorship)
- A person subject to a judicial protective measure
- A person who is not enrolled in or eligible for a social security program
- Subject does not speak French
- Subjects with a pacemaker or any other contraindication to MRI
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 |
|---|---|---|
| Blood sampleHormone and metabolic tests (insulin, IGF-1, leptin, blood glucose, ghrelin) | Biological | Male subjects |
| Brain MRI without contrast, performed on an empty stomach and after a mealMeasurement of the T1 and T2 relaxation times in the hypothalamic region | Procedure or surgery | Male subjects |
| QuestionnairesEating habits and preferences | Other | Male subjects |
| Bioelectrical impedance analysisMeasurements of lean body mass, fat mass, body water and bone mass | Other | Male subjects |
Primary outcome
The difference in hypothalamic MRI signal intensity between the baseline state and the postprandial state observed after a balanced meal and after a high-fat meal for each subject.
Time frame: 2 days
Measurement of hypothalamic T2 relaxation time
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 2026.
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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?
An observational study of Pathophysiology, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 10 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 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 France. 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 Vincent SCHNEIDER (03 80 29 30 89 ext. +33, vincent.schneider@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in hypothalamic MRI signal intensity between the baseline state and the postprandial state observed after a balanced meal and after a high-fat meal for each subject. (time frame: 2 days). 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 2026.