Binge Eating and Chromium Study

NCT ID: NCT00904306

Last Updated: 2012-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-07-31

Brief 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).

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.

Conditions

Binge Eating Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sugar pill

6 months treatment with placebo

Group Type: PLACEBO_COMPARATOR

Sugar Pill

Intervention Type: DIETARY_SUPPLEMENT

placebo oral tablet taken once per day

low dose

600ug/day chromium picolinate for 6 months

Group Type: ACTIVE_COMPARATOR

chromium picolinate

Intervention Type: DIETARY_SUPPLEMENT

600 ug/day chromium picolinate

high dose chromium picolinate

1000 ug/day

Group Type: ACTIVE_COMPARATOR

chromium picolinate

Intervention Type: DIETARY_SUPPLEMENT

1000 ug/day chromium picolinate for 6 months

Interventions

Sugar Pill

placebo oral tablet taken once per day

Intervention Type: DIETARY_SUPPLEMENT

chromium picolinate

1000 ug/day chromium picolinate for 6 months

Intervention Type: DIETARY_SUPPLEMENT

chromium picolinate

600 ug/day chromium picolinate

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Brownley

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly A Brownley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

References

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. doi: 10.1002/eat.20370.

Reference Type: BACKGROUND

PMID: 17370289 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 18188431 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17628126 (View on PubMed)

Brownley KA, Von Holle A, Hamer RM, La Via M, Bulik CM. A double-blind, randomized pilot trial of chromium picolinate for binge eating disorder: results of the Binge Eating and Chromium (BEACh) study. J Psychosom Res. 2013 Jul;75(1):36-42. doi: 10.1016/j.jpsychores.2013.03.092. Epub 2013 Apr 22.

Reference Type: DERIVED

PMID: 23751236 (View on PubMed)

Other Identifiers

08-0953 (GCRC #2713)

Identifier Type: -

Identifier Source: secondary_id

3062-04003

Identifier Type: -

Identifier Source: org_study_id