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CompletedNCT00904306BEAChUpdated Apr 3, 2012

Binge Eating and Chromium Study

A Phase 1/2 interventional study of Sugar Pill and chromium picolinate in Binge Eating Disorder, sponsored by University of North Carolina, Chapel Hill. Completed. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2012-04-03.

Sponsored by University of North Carolina, Chapel Hill · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Binge Eating Disorder

Keywords

  • binge eating
  • chromium
  • mood
  • glucose
  • appetite
03

In context

Bulimia

319 studies on the registry are indexed under Bulimia; 53 are open to participants now.

This study's enrollment of 26 is below the median of 61 across 249 interventional studies indexed under Bulimia.

Browse Bulimia studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Placebo comparator
    Sugar pill

    6 months treatment with placebo

    Dietary Supplement: Sugar Pill

  • Active comparator
    low dose

    600ug/day chromium picolinate for 6 months

    Dietary Supplement: chromium picolinate

  • Active comparator
    high dose chromium picolinate

    1000 ug/day

    Dietary Supplement: chromium picolinate

Interventions

  • Dietary supplementSugar Pill

    placebo oral tablet taken once per day

  • Dietary supplementchromium picolinate

    1000 ug/day chromium picolinate for 6 months

  • Dietary supplementchromium picolinate

    600 ug/day chromium picolinate

06

What researchers measure

Primary outcomes

  1. binge eating frequency

    Time frame: baseline, 3 and 6 months, 3-month followup

Secondary outcomes

  1. mood

    Time frame: baseline, 3 adn 6 months, 3-month followup

  2. insulin sensitivity

    Time frame: baseline, 3 adn 6 months, 3-month followup

  3. body weight

    Time frame: baseline, 3 adn 6 months, 3-month followup

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 17370289 ↗
  • Bulik CM, Brownley KA, Shapiro JR. Diagnosis and management of binge eating disorder. World Psychiatry. 2007 Oct;6(3):142-8. PubMed 18188431 ↗
  • 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. PubMed 17628126 ↗
  • 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. PubMed 23751236 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00904306
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
National Alliance for Research on Schizophrenia and Depression
Responsible party
Kimberly Brownley (Assistant Professor, University of North Carolina, Chapel Hill) — Principal investigator
First posted
May 19, 2009
Start date
Jul 2008
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Apr 3, 2012

Study contacts

Kimberly A Brownley, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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