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Binge Eating and Chromium Study (BEACh)

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Kimberly Brownley, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00904306
First received: May 17, 2009
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to test the feasibility and preliminary efficacy of a 6-month chromium picolinate (CrPic) treatment trial in binge eating disorder (BED).


Condition Intervention Phase
Binge Eating Disorder
Dietary Supplement: Sugar Pill
Dietary Supplement: chromium picolinate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chromium Picolinate in Binge Eating Disorder: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • binge eating frequency [ Time Frame: baseline, 3 and 6 months, 3-month followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mood [ Time Frame: baseline, 3 adn 6 months, 3-month followup ] [ Designated as safety issue: No ]
  • insulin sensitivity [ Time Frame: baseline, 3 adn 6 months, 3-month followup ] [ Designated as safety issue: No ]
  • body weight [ Time Frame: baseline, 3 adn 6 months, 3-month followup ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: July 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill
6 months treatment with placebo
Dietary Supplement: Sugar Pill
placebo oral tablet taken once per day
Active Comparator: low dose
600ug/day chromium picolinate for 6 months
Dietary Supplement: chromium picolinate
600 ug/day chromium picolinate
Active Comparator: high dose chromium picolinate
1000 ug/day
Dietary Supplement: chromium picolinate
1000 ug/day chromium picolinate for 6 months

Detailed Description:

Binge eating (i.e., the consumption of unusually large amounts of food with a sense of loss of control) is a common problem with serious public health implications in large part due to its role in obesity. Binge eating leads to weight gain and is common in overweight individuals. Current treatments for binge eating disorder (BED) are inadequate, and previous randomized treatment trials have suffered from high drop out rate due to the adverse effects of pharmacological agents. Chromium picolinate is a dietary supplement that has been shown to reduce symptoms of depression and appetite regulation problems in patients with atypical depression; chromium picolinate also affects insulin regulation and has been shown to improve glucose levels in patients with type-2 diabetes. This pilot study will evaluate the effect of chromium picolinate on binge eating, mood, body weight, and glucose regulation in overweight individuals with BED.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Currently meets DSM-IV criteria for binge eating disorder (BED);
  2. Is able to provide informed consent and meet study visit requirements; and
  3. Is psychiatrically stable (e.g., no current suicidal or homicidal intent or other psychiatric condition that requires acute intervention).

Exclusion Criteria:

  1. Body mass index (BMI) < 24.9 kg/m^2 (underweight or normal weight) or ≥ 40 kg/m^2 (severely obese);
  2. Postmenopausal;
  3. Age < 18 or > 55 years;
  4. Pregnant, planning on becoming pregnant during the study period, or lactating;
  5. Current psychotropic medication use;
  6. Current use of insulin or other medications to control glucose metabolism;
  7. Current use of medications known to significantly influence appetite or weight [i.e., over-the-counter appetite suppressants that contain phentermine or sibutramine, atypical antipsychotic agents with high weight gain liability (such as olanzapine, risperidone, etc), prednisone, etc.];
  8. Fasting glucose level > 126 mg/dL (indicative of diabetes); and
  9. Creatinine level indicating renal insufficiency (> 1.0 for women; > 1.2 for men).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904306

Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Kimberly A Brownley, PhD University of North Carolina, Chapel Hill
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kimberly Brownley, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00904306     History of Changes
Other Study ID Numbers: 3062-04003, 08-0953 (GCRC #2713)
Study First Received: May 17, 2009
Last Updated: April 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
binge eating
chromium
mood
glucose
appetite

Additional relevant MeSH terms:
Chromium
Eating Disorders
Binge-Eating Disorder
Bulimia
Disease
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes
Picolinic acid
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014