Amino Acids, Serotonin, and Body Weight Regulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Amino Acids, Serotonin, and Body Weight Regulation

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Other: Branched-chain amino acids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: Branched-chain amino acids<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and preoccupation with body image |  | Measured at Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating patterns |  | Measured at Week 9 |