Amino Acids, Serotonin, and Body Weight Regulation
Primary Purpose
Anorexia Nervosa
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Branched-chain amino acids
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
Eligibility Criteria
Inclusion Criteria: History of anorexia nervosa In normal weight range with resumed menses No recent bulimic episodes Persistent symptoms of anxiety Exclusion Criteria: Currently treated with psychotropic medication Diagnosed with major depression Current or recent substance dependence Serious medical illness Pregnant or breastfeeding
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Anxiety and preoccupation with body image
Secondary Outcome Measures
Eating patterns
Full Information
NCT ID
NCT00343928
First Posted
June 22, 2006
Last Updated
March 21, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00343928
Brief Title
Amino Acids, Serotonin, and Body Weight Regulation
Official Title
Amino Acids, Serotonin, and Body Weight Regulation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the behavioral effects of an amino acid mixture thought to influence serotonin function in individuals who have recovered from anorexia nervosa.
Detailed Description
Anorexia nervosa is a serious psychiatric disorder resulting in psychosocial distress for patients and their families, potentially severe medical consequences, and substantial long-term mortality. A major emphasis in current therapeutic research in anorexia nervosa is exploration of new interventions to stabilize recovery and prevent relapse. Although the etiology of anorexia nervosa is unknown, altered regulation of the neurotransmitter serotonin in the central nervous system is thought to contribute to preoccupation with body shape and weight, dysregulated eating patterns, persistent anxiety, and frequent mood fluctuations. The goal of this exploratory project is to assess the behavioral effects of an amino acid mixture thought to influence serotonin function in individuals who have recovered from anorexia nervosa. It is hypothesized that this brief intervention will help diminish residual eating disorder symptoms.
All participants in this crossover study will attend eight sessions over a 9-week period. Participants will spend approximately 2 weeks in each phase, during which they will receive an amino acid mixture and the control condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Branched-chain amino acids
Intervention Description
Participants will spend approximately 2 weeks in each phase over a 9-week period, during which they will receive an amino acid mixture and the placebo control condition.
Primary Outcome Measure Information:
Title
Anxiety and preoccupation with body image
Time Frame
Measured at Week 9
Secondary Outcome Measure Information:
Title
Eating patterns
Time Frame
Measured at Week 9
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of anorexia nervosa
In normal weight range with resumed menses
No recent bulimic episodes
Persistent symptoms of anxiety
Exclusion Criteria:
Currently treated with psychotropic medication
Diagnosed with major depression
Current or recent substance dependence
Serious medical illness
Pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Jimerson, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
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Amino Acids, Serotonin, and Body Weight Regulation
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