Binge Eating DisorderPhase 1/2BEAChNCT00904306
Binge Eating and Chromium Study
A Phase 1/2 study testing Sugar Pill and chromium picolinate in people with Binge Eating Disorder, run by University of North Carolina, Chapel Hill.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Sugar Pill and chromium picolinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Jul 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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).
About this study
Official title: 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).
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.
- Conditions
- Binge Eating Disorder
- Being tested
- Sugar Pill, chromium picolinate
- Keywords
- binge eating, chromium, mood, glucose, appetite
- Medical subject headings
- Binge-Eating Disorder, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar PillDietary supplement
placebo oral tablet taken once per day
chromium picolinateDietary supplement
1000 ug/day chromium picolinate for 6 months
chromium picolinateDietary supplement
600 ug/day chromium picolinate
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | 6 months treatment with placebo Receives: Dietary Supplement: Sugar Pill |
| low dose | Active comparator | 600ug/day chromium picolinate for 6 months Receives: Dietary Supplement: chromium picolinate |
| high dose chromium picolinate | Active comparator | 1000 ug/day Receives: Dietary Supplement: chromium picolinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
binge eating frequency
Measured: baseline, 3 and 6 months, 3-month followup
Secondary outcomes (3)
mood
Measured: baseline, 3 adn 6 months, 3-month followup
insulin sensitivity
Measured: baseline, 3 adn 6 months, 3-month followup
body weight
Measured: baseline, 3 adn 6 months, 3-month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Principal investigator, Kimberly Brownley, University of North Carolina, Chapel Hill
- Investigators
- Kimberly A Brownley, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904306
- Sponsor's protocol ID
- 3062-04003
- Other IDs
- 08-0953 (GCRC #2713)
- Acronym
- BEACh
- Status last verified
- Apr 2012
- First submitted
- 17 May 2009
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 17370289Bulik CM, Brownley KA, Shapiro JR. Diagnosis and management of binge eating disorder. World Psychiatry. 2007 Oct;6(3):142-8.
PubMed 18188431Berkman 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 17628126Brownley 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chromium Picolinate in Binge Eating Disorder: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00904306
- Acronym / sponsor ID
- BEACh / 3062-04003
- Conditions
- Binge Eating Disorder
- Keywords
- binge eating, chromium, mood, glucose, appetite
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Jul 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Dietary Supplement: Sugar Pill6 months treatment with placebo |
| low dose | Active comparator | Dietary Supplement: chromium picolinate600ug/day chromium picolinate for 6 months |
| high dose chromium picolinate | Active comparator | Dietary Supplement: chromium picolinate1000 ug/day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugar Pillplacebo oral tablet taken once per day | Dietary supplement | Sugar pill |
| chromium picolinate1000 ug/day chromium picolinate for 6 months | Dietary supplement | high dose chromium picolinate |
| chromium picolinate600 ug/day chromium picolinate | Dietary supplement | low dose |
Primary outcome
binge eating frequency
Time frame: baseline, 3 and 6 months, 3-month followup
3 secondary outcomes
mood
Time frame: baseline, 3 adn 6 months, 3-month followup
insulin sensitivity
Time frame: baseline, 3 adn 6 months, 3-month followup
body weight
Time frame: baseline, 3 adn 6 months, 3-month followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
- Background: PubMed 17370289Brownley 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.
- Background: PubMed 18188431Bulik CM, Brownley KA, Shapiro JR. Diagnosis and management of binge eating disorder. World Psychiatry. 2007 Oct;6(3):142-8.
- Background: PubMed 17628126Berkman 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.
- Derived from this study: PubMed 23751236Brownley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly A Brownley, PhD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sugar Pill and chromium picolinate in people with Binge Eating Disorder, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
binge eating frequency (time frame: baseline, 3 and 6 months, 3-month followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00904306, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2012.