Binge Eating and Chromium Study (BEACh)

April 2, 2012 updated by: Kimberly Brownley, University of North Carolina, Chapel Hill

Chromium Picolinate in Binge Eating Disorder: A Feasibility Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
1000 ug/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
Dietary supplement: chromium picolinate
600 ug/day chromium picolinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
binge eating frequency
Time Frame: baseline, 3 and 6 months, 3-month followup
baseline, 3 and 6 months, 3-month followup

Secondary Outcome Measures

Outcome Measure
Time Frame
mood
Time Frame: baseline, 3 adn 6 months, 3-month followup
baseline, 3 adn 6 months, 3-month followup
insulin sensitivity
Time Frame: baseline, 3 adn 6 months, 3-month followup
baseline, 3 adn 6 months, 3-month followup
body weight
Time Frame: baseline, 3 adn 6 months, 3-month followup
baseline, 3 adn 6 months, 3-month followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Alliance for Research on Schizophrenia and Depression

Investigators

  • Principal Investigator: Kimberly A Brownley, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

May 17, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 19, 2009

Study Record Updates

Last Update Posted (Estimate)

April 3, 2012

Last Update Submitted That Met QC Criteria

April 2, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3062-04003
  • 08-0953 (GCRC #2713)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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