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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Chu Dijon Bourgogne

    Dijon, 21000

    Vincent SCHNEIDER, 03 80 29 30 89 ext. +33, vincent.schneider@chu-dijon.fr

    Recruiting

Other trials in France

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.

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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 groups in NCT07557628
Study groupRoleWhat they receive
Male subjectsHealthy 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.

  1. 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.

  1. First posted29 Apr 2026
  2. Study start5 Sep 2026
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

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)
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

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.

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