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CompletedNCT00343928Updated Mar 23, 2017

Amino Acids, Serotonin, and Body Weight Regulation

A Phase 2 interventional study of Branched-chain amino acids in Anorexia Nervosa, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-03-23.

Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Anorexia Nervosa
03

In context

Anorexia

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

This study's enrollment of 21 is below the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • History of anorexia nervosa
  • In normal weight range with resumed menses
  • No recent bulimic episodes
  • Persistent symptoms of anxiety

Exclusion criteria

Exclusion Criteria:

  • Currently treated with psychotropic medication
  • Diagnosed with major depression
  • Current or recent substance dependence
  • Serious medical illness
  • Pregnant or breastfeeding
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    1

    Other: Branched-chain amino acids

Interventions

  • OtherBranched-chain amino acids

    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.

06

What researchers measure

Primary outcomes

  1. Anxiety and preoccupation with body image

    Time frame: Measured at Week 9

Secondary outcomes

  1. Eating patterns

    Time frame: Measured at Week 9

07

Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00343928
Lead sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Jun 23, 2006
Start date
Jun 2006
Primary completion
Jun 2008
Last update
Mar 23, 2017

Study contacts

David C. Jimerson, MD
principal investigator · Beth Israel Deaconess Medical Center

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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