NCT02112695

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

September 15, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2017

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2017

Enrollment Period

2.8 years

First QC Date

April 10, 2014

Last Update Submit

October 25, 2018

Conditions

Sports Nutritional Sciences

Keywords

endurance sportswomenaddictionundernutrition[11C]diprenorphine Petpituitary region

Outcome Measures

Primary Outcomes (1)

  • [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

    2 weeks

Secondary Outcomes (4)

  • correlation [11C]diprenorphine BP

    2 weeks

  • correlation [11C]diprenorphine BP

    2 weeks

  • correlation [11C]diprenorphine BP

    2 weeks

  • correlation [11C]diprenorphine BP

    2 weeks

Study Arms (2)

sportswomen

EXPERIMENTAL

3 micrograms \[11C\]diprenorphine

Other: [11C]diprenorphine

control subjects

EXPERIMENTAL

3 micrgrams \[11C\]diprenorphine

Other: [11C]diprenorphine

Interventions

[11C]diprenorphineOTHER

3 micrograms \[11C\]diprenorphine - intravenous use - 1 time

Also known as: radiopharmacentical precursor solution
control subjectssportswomen

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For High-level sportswomen :
  • year-old
  • High-level sportswomen
  • BMI\>19kg/m2
  • Absence of eating disorders
  • In pre-competition period
  • Signature of written consent
  • For controls :
  • year-old
  • Sedentary normal weight women
  • BMI\>19kg/m2
  • Normal nutritional markers
  • Absence of eating disorders or other psychiatric or organic diseases

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Endocrinologie - CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Behavior, AddictiveMalnutrition

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Bruno Estour, PU-PH

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 14, 2014

Study Start

September 15, 2014

Primary Completion

July 6, 2017

Study Completion

July 7, 2017

Last Updated

October 29, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)