Amino Acids, Serotonin, and Body Weight Regulation

March 21, 2017 updated by: Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Other: Branched-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anxiety and preoccupation with body image
Time Frame: Measured at Week 9
Measured at Week 9

Secondary Outcome Measures

Outcome Measure
Time Frame
Eating patterns
Time Frame: Measured at Week 9
Measured at Week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: David C. Jimerson, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

June 22, 2006

First Submitted That Met QC Criteria

June 22, 2006

First Posted (ESTIMATE)

June 23, 2006

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004P000107
  • R21MH071689 (NIH)
  • 2004P-000107 DATR A2-AID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe