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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00477854
Other study ID # PBRC 24040
Secondary ID
Status Completed
Phase N/A
First received May 23, 2007
Last updated February 11, 2016
Start date April 2005
Est. completion date May 2007

Study information

Verified date February 2016
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

Inclusion criteria are:

1. Healthy female who has not been diagnosed with diabetes, cardiovascular illness, or other chronic diseases,

2. Food craver, determined by self-reported craving for carbohydrates on two out of three validated measures of food cravings,

3. > 18 years of age and < 50 years of age, and

4. 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:

1. Participants who report smoking cigarettes will be excluded because of the effects of nicotine upon taste and appetite,

2. 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,

3. Participants who report using diet pills will be excluded since diet pills may potentially influence appetite, hunger, and/or satiety,

4. 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,

5. Participants who are not determined to be carbohydrate cravers will be excluded,

6. Participants will also be excluded if they report any allergies to the foods that will be used in the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Chromium Picolinate
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.

Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Pennington Biomedical Research Center Nutrition 21, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later 8 weeks No
Secondary Hunger and satiety between the lunch and dinner meal 8 weeks No
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