Amino Acids, Serotonin, and Body Weight Regulation

Beth Israel Lahey Health

Status and phase: Completed; Phase 2

Conditions: Anorexia Nervosa

Treatments: Other: Branched-chain amino acids

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00343928

2004P000107

2004P-000107 DATR A2-AID

R21MH071689 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 1 patient group

1

Experimental group

Treatment:

Other: Branched-chain amino acids