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Amino Acids, Serotonin, and Body Weight Regulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00343928
First Posted: June 23, 2006
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
  Purpose
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.

Condition Intervention Phase
Anorexia Nervosa Other: Branched-chain amino acids Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amino Acids, Serotonin, and Body Weight Regulation

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Anxiety and preoccupation with body image [ Time Frame: Measured at Week 9 ]

Secondary Outcome Measures:
  • Eating patterns [ Time Frame: Measured at Week 9 ]

Enrollment: 21
Study Start Date: June 2006
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343928


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: David C. Jimerson, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00343928     History of Changes
Other Study ID Numbers: 2004P000107
R21MH071689 ( U.S. NIH Grant/Contract )
2004P-000107 DATR A2-AID
First Submitted: June 22, 2006
First Posted: June 23, 2006
Last Update Posted: March 23, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Body Weight
Anorexia
Anorexia Nervosa
Signs and Symptoms
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs