ObesityNCT00477854
Effects of Chromium Picolinate on Food Intake
A study testing Chromium Picolinate in people with Obesity and Atypical Depression, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of chromium picolinate on food intake, food cravings, eating attitudes, and appetite. If chromium picolinate is found to have a beneficial impact on satiety and food intake, then this supplement may be an alternative or adjunctive treatment for overweight people… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Atypical Depression
- What is being tested?
- Chromium Picolinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to May 2007
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female who has not been diagnosed with diabetes, cardiovascular illness, or other chronic diseases,
- Food craver, determined by self-reported craving for carbohydrates on two out of three validated measures of food cravings,
- > 18 years of age and < 50 years of age, and
- Body mass index between 25 and 39.9 kg/m2. Participants will be scheduled for testing during the luteal phase of their menstrual cycle to limit the confounding effect of the menstrual cycle on energy intake. We will include women who are taking monophasic oral contraceptives but will exclude other oral contraceptive regimens. Participants with very irregular menstrual cycles will also be excluded because this irregularity will make it very difficult to schedule testing during the luteal phase of the menstrual cycle.
Who cannot join
- Potential participants will be excluded for the following reasons:
- Participants who report smoking cigarettes will be excluded because of the effects of nicotine upon taste and appetite,
- Participants who have a diagnosable eating disorder (i.e., anorexia or bulimia nervosa) will also be excluded since intentional restriction of eating and binge eating/overeating could increase the variability of the data,
- Participants who report using diet pills will be excluded since diet pills may potentially influence appetite, hunger, and/or satiety,
- Participants will be excluded if they are taking anti-depressant medications, anti-psychotic medications, or any medications that may potentially influence appetite, hunger, and/or satiety,
- Participants who are not determined to be carbohydrate cravers will be excluded,
- Participants will also be excluded if they report any allergies to the foods that will be used in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Effects of Chromium Picolinate on Food Intake, Satiety, and Eating Attitudes in Overweight Women With Food Cravings
The purpose of this study is to test the effects of chromium picolinate on food intake, food cravings, eating attitudes, and appetite. If chromium picolinate is found to have a beneficial impact on satiety and food intake, then this supplement may be an alternative or adjunctive treatment for overweight people desiring to modify their food intake. The primary hypothesis of this study is that among individuals who report being carbohydrate cravers, chromium picolinate supplementation will reduce food intake during a test lunch meal and produce greater satiety in comparison to a placebo.
- Conditions
- Obesity, Atypical Depression
- Being tested
- Chromium Picolinate
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromium PicolinateDrug
Test whether Chromium Picolinate supplementation affects food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later among healthy, overweight and/or obese, adult women who are determined to be carbohydrate creavers.
| Study group | Role | What they receive |
|---|---|---|
| Visual Analogue Scale Ratings | Experimental | Food intake data and its coefficients, including total food intake, food not eaten, duration of the meal, and bite rate. A mixed model analysis of variance will also be conducted on ratings of food cravings and eating atttudes. Changes in hunger and satiety ratings between, before, and after the meals will be compared for difference across treatment conditions. Receives: Drug: Chromium Picolinate |
| Consuming less Lunch allows consumption of more dinner | Experimental | Test whether chromium picolinate supplementation affects food cravings, eating attitudes, and satiety in healthy, overweight and/or obese, adult women who are determinded to be carbohydrate cravers. Whether participants who eat less at a lunch test meal consume more food at an ad lib dinner test meal with a diversity of foods. Receives: Drug: Chromium Picolinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later
Measured: 8 weeks
Secondary outcomes (1)
Hunger and satiety between the lunch and dinner meal
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startApr 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrition 21, Inc.
- Responsible party
- Principal investigator, William Cefalu, MD, Pennington Biomedical Research Center
- Investigators
- Stephen D Anton, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477854
- Sponsor's protocol ID
- PBRC 24040
- Status last verified
- Feb 2016
- First submitted
- 23 May 2007
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chromium Picolinate on Food Intake, Satiety, and Eating Attitudes in Overweight Women With Food Cravings
- ClinicalTrials.gov ID
- NCT00477854
- Acronym / sponsor ID
- PBRC 24040
- Conditions
- Obesity, Atypical Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Nutrition 21, Inc.
- Study start
- Apr 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 24 May 2007 (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 effects of chromium picolinate on food intake, food cravings, eating attitudes, and appetite. If chromium picolinate is found to have a beneficial impact on satiety and food intake, then this supplement may be an alternative or adjunctive treatment for overweight people desiring to modify their food intake. The primary hypothesis of this study is that among individuals who report being carbohydrate cravers, chromium picolinate supplementation will reduce food intake during a test lunch meal and produce greater satiety in comparison to a placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Analogue Scale Ratings | Experimental | Drug: Chromium PicolinateFood intake data and its coefficients, including total food intake, food not eaten, duration of the meal, and bite rate. A mixed model analysis of variance will also be conducted on ratings of food cravings and eating atttudes. Changes in hunger and satiety ratings between, before, and after the meals will be compared for difference across treatment conditions. |
| Consuming less Lunch allows consumption of more dinner | Experimental | Drug: Chromium PicolinateTest whether chromium picolinate supplementation affects food cravings, eating attitudes, and satiety in healthy, overweight and/or obese, adult women who are determinded to be carbohydrate cravers. Whether participants who eat less at a lunch test meal consume more food at an ad lib dinner test meal with a diversity of foods. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female who has not been diagnosed with diabetes, cardiovascular illness, or other chronic diseases,
- Food craver, determined by self-reported craving for carbohydrates on two out of three validated measures of food cravings,
- > 18 years of age and < 50 years of age, and
- Body mass index between 25 and 39.9 kg/m2. Participants will be scheduled for testing during the luteal phase of their menstrual cycle to limit the confounding effect of the menstrual cycle on energy intake. We will include women who are taking monophasic oral contraceptives but will exclude other oral contraceptive regimens. Participants with very irregular menstrual cycles will also be excluded because this irregularity will make it very difficult to schedule testing during the luteal phase of the menstrual cycle.
Key exclusion criteria (7 listed)
- Participants who report smoking cigarettes will be excluded because of the effects of nicotine upon taste and appetite,
- Participants who have a diagnosable eating disorder (i.e., anorexia or bulimia nervosa) will also be excluded since intentional restriction of eating and binge eating/overeating could increase the variability of the data,
- Participants who report using diet pills will be excluded since diet pills may potentially influence appetite, hunger, and/or satiety,
- Participants will be excluded if they are taking anti-depressant medications, anti-psychotic medications, or any medications that may potentially influence appetite, hunger, and/or satiety,
- Participants who are not determined to be carbohydrate cravers will be excluded,
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 |
|---|---|---|
| Chromium PicolinateTest whether Chromium Picolinate supplementation affects food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later among healthy, overweight and/or obese, adult women who are determined to be carbohydrate creavers. | Drug | Consuming less Lunch allows consumption of more dinner, Visual Analogue Scale Ratings |
Primary outcome
Food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later
Time frame: 8 weeks
1 secondary outcome
Hunger and satiety between the lunch and dinner meal
Time frame: 8 weeks
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 12 Feb 2016.
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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.
Stephen D Anton, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chromium Picolinate in people with Obesity and Atypical Depression, run by Pennington Biomedical Research Center at 1 site in United States.
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 4 inclusion and 7 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 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2016.