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Binge Eating and Chromium Study (BEACh)

Primary Purpose

Binge Eating Disorder

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Sugar Pill

chromium picolinate

About this trial

This is an interventional treatment trial for Binge Eating Disorder focused on measuring binge eating, chromium, mood, glucose, appetite

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sugar pill

low dose

high dose chromium picolinate

Arm Description

6 months treatment with placebo

600ug/day chromium picolinate for 6 months

1000 ug/day

Outcomes

Primary Outcome Measures

binge eating frequency

Secondary Outcome Measures

mood

insulin sensitivity

body weight

Full Information

NCT ID

NCT00904306

First Posted

May 17, 2009

Last Updated

April 2, 2012

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Alliance for Research on Schizophrenia and Depression

1. Study Identification

Unique Protocol Identification Number

NCT00904306

Brief Title

Binge Eating and Chromium Study

Acronym

BEACh

Official Title

Chromium Picolinate in Binge Eating Disorder: A Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Binge Eating Disorder

Keywords

binge eating, chromium, mood, glucose, appetite

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Arm Description

6 months treatment with placebo

Arm Title

low dose

Arm Type

Active Comparator

Arm Description

600ug/day chromium picolinate for 6 months

Arm Title

high dose chromium picolinate

Arm Type

Active Comparator

Arm Description

1000 ug/day

Intervention Type

Dietary Supplement

Intervention Name(s)

Sugar Pill

Intervention Description

placebo oral tablet taken once per day

Intervention Type

Dietary Supplement

Intervention Name(s)

chromium picolinate

Intervention Description

1000 ug/day chromium picolinate for 6 months

Intervention Type

Dietary Supplement

Intervention Name(s)

chromium picolinate

Intervention Description

600 ug/day chromium picolinate

Primary Outcome Measure Information:

Title

binge eating frequency

Time Frame

baseline, 3 and 6 months, 3-month followup

Secondary Outcome Measure Information:

Title

mood

Time Frame

baseline, 3 adn 6 months, 3-month followup

Title

insulin sensitivity

Time Frame

baseline, 3 adn 6 months, 3-month followup

Title

body weight

Time Frame

baseline, 3 adn 6 months, 3-month followup

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kimberly A Brownley, PhD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

17370289

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.

Results Reference

background

PubMed Identifier

18188431

Citation

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

Results Reference

background

PubMed Identifier

17628126

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.

Results Reference

background

PubMed Identifier

23751236

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.

Results Reference

derived

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Binge Eating and Chromium Study

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