Binge Eating and Chromium Study (BEACh)
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
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
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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:
- Currently meets DSM-IV criteria for binge eating disorder (BED);
- Is able to provide informed consent and meet study visit requirements; and
- Is psychiatrically stable (e.g., no current suicidal or homicidal intent or other psychiatric condition that requires acute intervention).
Exclusion Criteria:
- Body mass index (BMI) < 24.9 kg/m^2 (underweight or normal weight) or ≥ 40 kg/m^2 (severely obese);
- Postmenopausal;
- Age < 18 or > 55 years;
- Pregnant, planning on becoming pregnant during the study period, or lactating;
- Current psychotropic medication use;
- Current use of insulin or other medications to control glucose metabolism;
- 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.];
- Fasting glucose level > 126 mg/dL (indicative of diabetes); and
- Creatinine level indicating renal insufficiency (> 1.0 for women; > 1.2 for men).
Contacts and Locations
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
Additional Information:
Publications:
| 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:
|
Bulimia Binge-Eating Disorder Eating Disorders Hyperphagia Signs and Symptoms, Digestive Signs and Symptoms Mental Disorders Chromium Picolinic acid |
Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Iron Chelating Agents Chelating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013