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Effects of Chromium Picolinate on Food Intake

This study has been completed.
Sponsor:
Collaborator:
Nutrition 21, Inc.
Information provided by (Responsible Party):
William Cefalu, MD, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00477854
First received: May 23, 2007
Last updated: November 3, 2014
Last verified: November 2014

May 23, 2007
November 3, 2014
April 2005
May 2007   (final data collection date for 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 ] [ Designated as safety issue: No ]
Food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT00477854 on ClinicalTrials.gov Archive Site
Hunger and satiety between the lunch and dinner meal [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Hunger and satiety between the lunch and dinner meal [ Time Frame: 8 weeks ]
Not Provided
Not Provided
 
Effects of Chromium Picolinate on Food Intake
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Obesity
  • Atypical Depression
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.
  • 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.
    Intervention: Drug: Chromium Picolinate
  • 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.
    Intervention: Drug: Chromium Picolinate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00477854
PBRC24040
No
William Cefalu, MD, Pennington Biomedical Research Center
Pennington Biomedical Research Center
Nutrition 21, Inc.
Principal Investigator: Stephen D Anton, Ph.D. Pennington Biomedical Research Center
Pennington Biomedical Research Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP