Amino Acids, Serotonin, and Body Weight Regulation

Phase 2

Completed

• Conditions: Anorexia Nervosa
• Interventions: Other: Branched-chain amino acids

• Registration Number: NCT00343928
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-22
• Study First Submitted QC: 2006-06-22
• Study First Posted: 2006-06-23
• Primary Completion: 2008-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Branched-chain amino acids	-

Primary Outcome Measures

Name	Time	Method
Anxiety and preoccupation with body image	Measured at Week 9

Secondary Outcome Measures

Name	Time	Method
Eating patterns	Measured at Week 9

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States