Effects of Chromium Picolinate on Food Intake

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00477854
• Collaborator: Nutrition 21, Inc. (Industry)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Atypical Depression	Drug: Chromium Picolinate	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effects of Chromium Picolinate on Food Intake, Satiety, and Eating Attitudes in Overweight Women With Food Cravings
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: May 1, 2007
• Actual Study Completion Date: May 1, 2007

Arms and Interventions

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.	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: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later [8 weeks]

Secondary Outcome Measures

1. Hunger and satiety between the lunch and dinner meal [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Pennington Biomedical Research Center
• Nutrition 21, Inc.

Investigators

• Principal Investigator: Stephen D Anton, Ph.D., Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Cefalu, MD, Principal Investigator, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT00477854
• Other Study ID Numbers: PBRC 24040
• First Posted: May 24, 2007
• Last Update Posted: Feb 12, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Depression; Chromium; Picolinic acid

Study Results

No Results Posted as of Feb 12, 2016