NCT00477854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

2.1 years

First QC Date

May 23, 2007

Last Update Submit

February 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later

    8 weeks

Secondary Outcomes (1)

  • Hunger and satiety between the lunch and dinner meal

    8 weeks

Study Arms (2)

Visual Analogue Scale Ratings

EXPERIMENTAL

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

Consuming less Lunch allows consumption of more dinner

EXPERIMENTAL

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

Interventions

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.

Consuming less Lunch allows consumption of more dinnerVisual Analogue Scale Ratings

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

picolinic acid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen D Anton, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

April 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations