- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00477854
Effects of Chromium Picolinate on Food Intake
February 11, 2016 updated by: William Cefalu, MD, Pennington Biomedical Research Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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-
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
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Inclusion criteria are:
- 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.
Exclusion Criteria:
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.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Visual Analogue Scale Ratings
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.
|
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.
|
Experimental: Consuming less Lunch allows consumption of more dinner
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hunger and satiety between the lunch and dinner meal
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stephen D Anton, Ph.D., Pennington Biomedical Research Center
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
April 1, 2005
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
May 23, 2007
First Submitted That Met QC Criteria
May 23, 2007
First Posted (Estimate)
May 24, 2007
Study Record Updates
Last Update Posted (Estimate)
February 12, 2016
Last Update Submitted That Met QC Criteria
February 11, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 24040
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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