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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
  Purpose

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 Intervention
Obesity
Atypical Depression
Drug: Chromium Picolinate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Chromium Picolinate on Food Intake, Satiety, and Eating Attitudes in Overweight Women With Food Cravings

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Hunger and satiety between the lunch and dinner meal [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: April 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477854

Locations
United States, Louisiana
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
  More Information

No publications provided

Responsible Party: William Cefalu, MD, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00477854     History of Changes
Other Study ID Numbers: PBRC24040
Study First Received: May 23, 2007
Last Updated: November 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Chromium
Picolinic acid
Chelating Agents
Growth Substances
Iron Chelating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sequestering Agents
Trace Elements

ClinicalTrials.gov processed this record on November 27, 2014