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CompletedNCT02333500Updated Feb 26, 2019

Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa

An interventional study of olfactory workshop and other workshop in Anorexia, sponsored by Fondation Lenval. Completed at 1 site in France. Open to participants aged 11 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Fondation Lenval · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
11 Years to 18 Years
Sex
All
01

Study summary

This prospective pilot study will compare adolescents with restrictive anorexia nervosa who participated for 3 months at olfactory workshops, patients who did not, and healthy patients.The groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level.

Read the detailed description

The restrictive anorexia nervosa (AN) in adolescents is an eating disorder with decreased desire to eat (wanting) following olfactory stimulation. Oxytocin is an hormone involved in the neuromodulation of eating behavior, but also involved in olfactory perception in schizophrenia patients, and in social cognition in patients with autism. Its plasma level was found low in anorexic patients compared to control subjects.

Because of the similarity in disorders of social cognition between these three diseases, we assume that the desire to eat evoked by olfactory perception varies with the plasma oxytocin levels.

With a prospective pilot study we will compare patients with AN who participated for 3 months at olfactory workshops, AN patients who did not, and healthy patients.

The groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level.

One application of this study will be the use of ocytocyne nasal spray to increase the eating desire and to allow weight regain

02

Conditions studied

  • Anorexia
03

In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's enrollment of 30 is below the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

Fondation Lenval is the lead sponsor of 60 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Medical-Review
  • Female or male -Sexe,
  • 11 to 18 years
  • Anorexia nervosa diagnosed according to the criteria DSM V
  • Outpatient care or hospitalization
  • Be able to answer the clinicals evaluations questionnaires
  • Affiliated to social security
  • Consentement of the legal representative and the patient

Exclusion criteria

Exclusion Criteria:

  • Somatic comorbidity associated with diabetes, celiac disease, brain tumor
  • Intolerance odors, predisposed to develop asthma and / or respiratory allergies Pathologie chronic rhino-sinus
  • Hyposmiques or anosmic
  • Patients not of an inclusion criteria
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    olfactory workshop

    Influence of sensory therapy on the rate of oxytocin

    Other: olfactory workshop

  • Active comparator
    other workshop

    Influence of other workshop on the rate of oxytocin

    Other: other workshop

  • Other
    control group

    Rate of oxytocin of the control group

    Other: No intervention

Interventions

  • Otherolfactory workshop

    olfactory workshop

  • Otherother workshop

    other workshop: discussion group, dance and body Expression

  • OtherNo intervention

    control group

06

What researchers measure

Primary outcomes

  1. Score "Wanting" to olfactory stimuli

    Time frame: at 3 months

Secondary outcomes

  1. Oxytocin serum level

    Time frame: at 3 months

  2. Body mass index

    Time frame: at 3 months

  3. Scores to clinical scales

    Time frame: at 3 months

  4. Scores to hedonicity scale

    Time frame: at 3 months

  5. Scores to "liking"-"wanting" tests

    Time frame: at 3 months

07

Study locations

1 site
  • Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval
    Nice, 06200, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02333500
Lead sponsor
Fondation Lenval
Responsible party
Sponsor
First posted
Jan 7, 2015
Start date
Feb 11, 2015
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Feb 26, 2019

Study contacts

Florence ASKENAZY, PU-PH
principal investigator · Hôpitaux pediatriques CHU de Nice Fondation Lenval

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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