NCT00904306

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2008

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 3, 2012

Status Verified

April 1, 2012

Enrollment Period

3 years

First QC Date

May 17, 2009

Last Update Submit

April 2, 2012

Conditions

Binge Eating Disorder

Keywords

binge eatingchromiummoodglucoseappetite

Outcome Measures

Primary Outcomes (1)

  • binge eating frequency

    baseline, 3 and 6 months, 3-month followup

Secondary Outcomes (3)

  • mood

    baseline, 3 adn 6 months, 3-month followup

  • insulin sensitivity

    baseline, 3 adn 6 months, 3-month followup

  • body weight

    baseline, 3 adn 6 months, 3-month followup

Study Arms (3)

Sugar pill

PLACEBO COMPARATOR

6 months treatment with placebo

Dietary Supplement: Sugar Pill

low dose

ACTIVE COMPARATOR

600ug/day chromium picolinate for 6 months

Dietary Supplement: chromium picolinate

high dose chromium picolinate

ACTIVE COMPARATOR

1000 ug/day

Dietary Supplement: chromium picolinate

Interventions

Sugar PillDIETARY_SUPPLEMENT

placebo oral tablet taken once per day

Sugar pill
chromium picolinateDIETARY_SUPPLEMENT

1000 ug/day chromium picolinate for 6 months

high dose chromium picolinate

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 17370289BACKGROUND

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

    PMID: 18188431BACKGROUND

  • 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.

    PMID: 17628126BACKGROUND

  • 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.

    PMID: 23751236DERIVED

MeSH Terms

Conditions

Binge-Eating DisorderBulimia

Interventions

Sugarspicolinic acid

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Kimberly A Brownley, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 17, 2009

First Posted

May 19, 2009

Study Start

July 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 3, 2012

Record last verified: 2012-04