Clinical trial NCT00904306: Binge Eating and Chromium Study
Official title: Chromium Picolinate in Binge Eating Disorder: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Binge Eating Disorder
Keywords: binge eating
chromium
mood
glucose
appetite
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2009-05-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: binge eating frequency
timeFrame: baseline, 3 and 6 months, 3-month followup
Secondary outcomes:
measure: mood
timeFrame: baseline, 3 adn 6 months, 3-month followup
measure: insulin sensitivity
timeFrame: baseline, 3 adn 6 months, 3-month followup
measure: body weight
timeFrame: baseline, 3 adn 6 months, 3-month followup
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kimberly A Brownley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1002/eat.20370.
citation: Bulik CM, Brownley KA, Shapiro JR. Diagnosis and management of binge eating disorder. World Psychiatry. 2007 Oct;6(3):142-8.
citation: 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.
citation: 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.