Sports Nutritional SciencesNCT02112695
Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study
A study testing [11C]diprenorphine in people with Sports Nutritional Sciences, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Abnormal opioid system have been identified in addictive behavior and activity of the opioid system has also shown a strong link with the nutritional balance. A significant increase in endorphin levels was noticed after exercise, proportional to the duration and intensity of this activity. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Nutritional Sciences
- What is being tested?
- [11C]diprenorphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2014to 7 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- For High-level sportswomen :
- 18-35-year-old
- High-level sportswomen
- BMI>19kg/m2
- Absence of eating disorders
- In pre-competition period
Show all 13Show fewer
- Signature of written consent
- For controls :
- 18-35-year-old
- Sedentary normal weight women
- BMI>19kg/m2
- Normal nutritional markers
- Absence of eating disorders or other psychiatric or organic diseases
Who cannot join
- Oral contraception
- Heart failure
- Neuroleptics, antiparkinson drugs, alpha-methyl-dopa, beta blockers, inhibitors of monoamine oxidase-A or MOA-B, tricyclic antidepressants, selective serotonin reuptake inhibitor, thyme-regulators (lithium), anticonvulsant drugs, codeine, morphine, drugs containing tramadol, dopaminergic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Abnormal opioid system have been identified in addictive behavior and activity of the opioid system has also shown a strong link with the nutritional balance. A significant increase in endorphin levels was noticed after exercise, proportional to the duration and intensity of this activity. One brain imaging study showed an increase in opioid activity in athletes after endurance training. However , a decrease in opioid tone related to receptor desensitization in the brain has been raised in the sport and it is possible to feel like , the subject must perform physical exercise more frequently . Consequently, in order to deepen the hypothesis of addiction in high-level sport , the brain opioid activity should be assessed pre- training compared to a group of sedentary control subjects .
Preliminary results of a previous study the investigators are conducting on anorexia nervosa (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and the regulation of gonadal function. However, the relation of cause and effect between these anomalies and undernutrition remains to be determined . Given the addictive component in the endurance sport and the variability of the nutritional status of its practitioners , evaluation of brain activity in these subjects could provide additional answers.
- Conditions
- Sports Nutritional Sciences
- Being tested
- [11C]diprenorphine
- Keywords
- endurance sportswomen, addiction, undernutrition, [11C]diprenorphine Pet, pituitary region
- Medical subject headings
- Behavior, Addictive, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]diprenorphineOther
Also called radiopharmacentical precursor solution
3 micrograms [11C]diprenorphine - intravenous use - 1 time
| Study group | Role | What they receive |
|---|---|---|
| sportswomen | Experimental | 3 micrograms [11C]diprenorphine Receives: Other: [11C]diprenorphine |
| control subjects | Experimental | 3 micrgrams [11C]diprenorphine Receives: Other: [11C]diprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
[11C]diprenorphine binding potential
Value of [11C]diprenorphin binding potential in predifined brains regions. [11C]diprenorphin BP will be evaluated by brain positron emission tomography and MRI exam
Measured: 2 weeks
Secondary outcomes (4)
correlation [11C]diprenorphine BP
Correlation between [11C]Diprenorphine binding potential and plasma endogenous opioid levels
Measured: 2 weeks
correlation [11C]diprenorphine BP
Correlation between [11C]Diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement
Measured: 2 weeks
correlation [11C]diprenorphine BP
Correlation between [11C]Diprenorphine binding potential and appetite regulating hormones
Measured: 2 weeks
correlation [11C]diprenorphine BP
Correlation between [11C]Diprenorphine binding potential and LH response during GnRH test
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study start15 Sep 2014
- Primary completion6 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Nutritional SciencesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Bruno Estour, PU-PH, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112695
- Sponsor's protocol ID
- 1208051
- Other IDs
- 2013-004733-32
- Status last verified
- Oct 2017
- First submitted
- 10 Apr 2014
- Last updated
- 29 Oct 2018
- 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 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study
- ClinicalTrials.gov ID
- NCT02112695
- Acronym / sponsor ID
- 1208051
- Conditions
- Sports Nutritional Sciences
- Keywords
- endurance sportswomen, addiction, undernutrition, [11C]diprenorphine Pet, pituitary region
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 14 Apr 2014 (estimated)
- 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.
Abnormal opioid system have been identified in addictive behavior and activity of the opioid system has also shown a strong link with the nutritional balance. A significant increase in endorphin levels was noticed after exercise, proportional to the duration and intensity of this activity. One brain imaging study showed an increase in opioid activity in athletes after endurance training. However , a decrease in opioid tone related to receptor desensitization in the brain has been raised in the sport and it is possible to feel like , the subject must perform physical exercise more frequently . Consequently, in order to deepen the hypothesis of addiction in high-level sport , the brain opioid activity should be assessed pre- training compared to a group of sedentary control subjects .
Preliminary results of a previous study the investigators are conducting on anorexia nervosa (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and the regulation of gonadal function. However, the relation of cause and effect between these anomalies and undernutrition remains to be determined . Given the addictive component in the endurance sport and the variability of the nutritional status of its practitioners , evaluation of brain activity in these subjects could provide additional answers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sportswomen | Experimental | Other: [11C]diprenorphine3 micrograms [11C]diprenorphine |
| control subjects | Experimental | Other: [11C]diprenorphine3 micrgrams [11C]diprenorphine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 18-35-year-old
- High-level sportswomen
- BMI>19kg/m2
- Absence of eating disorders
- In pre-competition period
Key exclusion criteria (3 listed)
- Oral contraception
- Heart failure
- Neuroleptics, antiparkinson drugs, alpha-methyl-dopa, beta blockers, inhibitors of monoamine oxidase-A or MOA-B, tricyclic antidepressants, selective serotonin reuptake inhibitor, thyme-regulators (lithium), anticonvulsant drugs, codeine, morphine, drugs containing tramadol, dopaminergic drugs
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 |
|---|---|---|
| [11C]diprenorphineAlso: radiopharmacentical precursor solution3 micrograms [11C]diprenorphine - intravenous use - 1 time | Other | control subjects, sportswomen |
Primary outcome
[11C]diprenorphine binding potential
Time frame: 2 weeks
Value of [11C]diprenorphin binding potential in predifined brains regions. [11C]diprenorphin BP will be evaluated by brain positron emission tomography and MRI exam
4 secondary outcomes
correlation [11C]diprenorphine BP
Time frame: 2 weeks
correlation [11C]diprenorphine BP
Time frame: 2 weeks
correlation [11C]diprenorphine BP
Time frame: 2 weeks
correlation [11C]diprenorphine BP
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- 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. This study is not recruiting at the moment.
Bruno Estour, PU-PH principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [11C]diprenorphine in people with Sports Nutritional Sciences, run by Centre Hospitalier Universitaire de Saint Etienne 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 13 inclusion and 3 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: finished, as of the sponsor's last update on 29 Oct 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[11C]diprenorphine binding potential (time frame: 2 weeks). 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 Oct 2018.