Binge Eating and Chromium Study

Binge Eating Disorder Clinical Trial

— BEACh  

Official title:

Chromium Picolinate in Binge Eating Disorder: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904306
• Other study ID #: 3062-04003
• Secondary ID: 08-0953 (GCRC #2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 17, 2009
• Last updated: April 2, 2012
• Start date: July 2008
• Est. completion date: July 2011

Study information

• Verified date: April 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders

Intervention

Dietary Supplement:
• Sugar Pill
placebo oral tablet taken once per day
• chromium picolinate
1000 ug/day chromium picolinate for 6 months
• chromium picolinate
600 ug/day chromium picolinate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Alliance for Research on Schizophrenia and Depression

References & Publications (3)

Berkman ND, Bulik CM, Brownley KA, Lohr KN, Sedway JA, Rooks A, Gartlehner G. Management of eating disorders. Evid Rep Technol Assess (Full Rep). 2006 Apr;(135):1-166. Review. — View Citation

Brownley KA, Berkman ND, Sedway JA, Lohr KN, Bulik CM. Binge eating disorder treatment: a systematic review of randomized controlled trials. Int J Eat Disord. 2007 May;40(4):337-48. Review. — View Citation

Bulik CM, Brownley KA, Shapiro JR. Diagnosis and management of binge eating disorder. World Psychiatry. 2007 Oct;6(3):142-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	binge eating frequency		baseline, 3 and 6 months, 3-month followup	No
Secondary	mood		baseline, 3 adn 6 months, 3-month followup	No
Secondary	insulin sensitivity		baseline, 3 adn 6 months, 3-month followup	No
Secondary	body weight		baseline, 3 adn 6 months, 3-month followup	No