Food AddictionMiRACleNCT07830680
Physiopathology of Behavioral Addictions and Biomarkers
An observational study of Food Addiction and Sexual Addiction, run by Nantes University Hospital at 1 site in France.
Trial summary
The goal of this observational study is to evaluate the expression of miR-10a-5p in the blood in patients with sexual addiction or food addiction. The main question it aims to answer is : To determine whether adults patients with SA or FA exhibit a distinct blood miR-10a-5p expression profile compared with matched… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Addiction, Sexual Addiction
- What is being tested?
- blood sampling
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 30 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with food or sexual addiction, compared with age- and sex-matched healthy controls with no current addictive disorder.
Who may be able to join
- For patients with FA:
- Male and females ≥ 18 years old
- Already in care or newly initiating care
- Participating to EVALADD cohort
- Current diagnosis of FA
- Oral consent provided
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- Affiliated with French social security system or beneficiary from such system
- For healthy controls matched to patients with FA:
- Male and females ≥ 18 years old
- Oral consent provided
- Affiliated with French social security system or beneficiary from such system
- For patients with SA:
- Male ≥ 18 years old
- Already in care or newly initiating care
- Participating to EVALADD cohort
- Current diagnosis of SA
- Oral consent provided
- Affiliated with French social security system or beneficiary from such system
- For healthy controls matched to patients with SA:
- Male ≥ 18 years old
- Oral consent provided
- Affiliated with French social security system or beneficiary from such system
Who cannot join
- For patients with FA:
- Presence of a current diagnosis of SA
- Presence of any current addictive disorder (substance [except tobacco] use disorders, gambling disorder, gaming disorder)
- Presence of any current instable psychiatric disorder (requiring the initiation or adapation of medication)
- Pregnancy or breastfeeding woman
- Trusteeship or curatorship
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- Major cognitive impairment
- Not fluent in French
- For patients with SA:
- Presence of a current diagnosis of FA
- Presence of any current addictive disorder (substance [except tobacco] use disorders, gambling disorder, gaming disorder)
- Presence of any current instable psychiatric disorder (requiring the initiation or adapation of medication)
- Trusteeship or curatorship
- Major cognitive impairment
- Not fluent in French
- For healthy controls:
- Without a current diagnosis of FA
- Without a current diagnosis of SA
- Presence of any current addictive disorder (substance [except tobacco] use disorders, gambling disorder, gaming disorder)
- Presence of any current instable psychiatric disorder (requiring the initiation or adapation of medication)
- Pregnancy or breastfeeding woman
- Trusteeship or curatorship
- Major cognitive impairment
- Not fluent in French
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
Nantes University Hospital
Nantes
Gaëlle CHALLET, 02.40.84.76.20, gaelle.bouju@chu-nantes.fr
About this study
Official title: Physiopathology of Behavioral Addictions and Biomarkers: microRNAs Implication - MiRACle : a Pilot Study.
The goal of this observational study is to evaluate the expression of miR-10a-5p in the blood in patients with sexual addiction or food addiction. The main question it aims to answer is : To determine whether adults patients with SA or FA exhibit a distinct blood miR-10a-5p expression profile compared with matched healthy controls.
For all participants, one blood sample will be collected.
- Conditions
- Food Addiction, Sexual Addiction
- Being tested
- blood sampling
- Medical subject headings
- Food Addiction, Compulsive Sexual Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
One blood sample wiil be collected into a 10mL K2EDTA BD Vacutainer® tube
| Study group | Role | What they receive |
|---|---|---|
| Patients with addiction | Patients with food addiction (FA) or sexual addiction Receives: Biological: blood sampling | |
| Healthy controls | Healthy controls matched on sex and age to patients with food addiction or sexual addiction Receives: Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood miR-10a-5p expression
The concentration of each miR-enriched fraction will be determined by spectrophotometric between patients with SA or FA and matched healthy controls.
Measured: 3 months
Secondary outcomes (7)
Blood additional circulating miRs expression
The concentration of circulating miRs fraction will be determined by spectrophotometric between patients with SA or FA and matched healthy controls.
Measured: 3 months
Clinical Characteristics
Association between blood expression levels of circulating miRs and age
Measured: 3 months
Clinical Characteristics
Association between blood expression levels of circulating miRs and sex
Measured: 3 months
Clinical Characteristics
Association between blood expression levels of circulating miRs and duration of addiction
Measured: 3 months
Clinical Characteristics
Association between blood expression levels of circulating miRs and severity of addiction
Measured: 3 months
Clinical Characteristics
Association between blood expression levels of circulating miRs and tobacco-use
Measured: 3 months
Clinical Characteristics
Association between blood expression levels of circulating miRs and psychiatric disorders
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AddictionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U1216 Grenoble Institut des Neurosciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830680
- Sponsor's protocol ID
- RC26_0091
- Acronym
- MiRACle
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 24 Sep 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathology of Behavioral Addictions and Biomarkers: microRNAs Implication - MiRACle : a Pilot Study.
- ClinicalTrials.gov ID
- NCT07830680
- Acronym / sponsor ID
- MiRACle / RC26_0091
- Conditions
- Food Addiction, Sexual Addiction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- INSERM U1216 Grenoble Institut des Neurosciences
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Sep 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.
The goal of this observational study is to evaluate the expression of miR-10a-5p in the blood in patients with sexual addiction or food addiction. The main question it aims to answer is : To determine whether adults patients with SA or FA exhibit a distinct blood miR-10a-5p expression profile compared with matched healthy controls.
For all participants, one blood sample will be collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with addiction | – | Biological: blood samplingPatients with food addiction (FA) or sexual addiction |
| Healthy controls | – | Biological: blood samplingHealthy controls matched on sex and age to patients with food addiction or sexual addiction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with food or sexual addiction, compared with age- and sex-matched healthy controls with no current addictive disorder.
Key inclusion criteria (22 listed)
- Male and females ≥ 18 years old
- Already in care or newly initiating care
- Participating to EVALADD cohort
- Current diagnosis of FA
- Oral consent provided
Key exclusion criteria (24 listed)
- Presence of a current diagnosis of SA
- Presence of any current addictive disorder (substance [except tobacco] use disorders, gambling disorder, gaming disorder)
- Presence of any current instable psychiatric disorder (requiring the initiation or adapation of medication)
- Pregnancy or breastfeeding woman
- Trusteeship or curatorship
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 samplingOne blood sample wiil be collected into a 10mL K2EDTA BD Vacutainer® tube | Biological | Healthy controls, Patients with addiction |
Primary outcome
Blood miR-10a-5p expression
Time frame: 3 months
The concentration of each miR-enriched fraction will be determined by spectrophotometric between patients with SA or FA and matched healthy controls.
7 secondary outcomes
Blood additional circulating miRs expression
Time frame: 3 months
Clinical Characteristics
Time frame: 3 months
Clinical Characteristics
Time frame: 3 months
Clinical Characteristics
Time frame: 3 months
Clinical Characteristics
Time frame: 3 months
Clinical Characteristics
Time frame: 3 months
Clinical Characteristics
Time frame: 3 months
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 24 Sep 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?
An observational study of Food Addiction and Sexual Addiction, run by Nantes University Hospital 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 22 inclusion and 24 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 24 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 Pr Caroline Victorri-Vigneau (02.40.84.76.20, marie.bronnec@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood miR-10a-5p expression (time frame: 3 months). 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 24 Sep 2026.