Clinical trial NCT00477854: Effects of Chromium Picolinate on Food Intake
Official title: Effects of Chromium Picolinate on Food Intake, Satiety, and Eating Attitudes in Overweight Women With Food Cravings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Atypical Depression
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Nutrition 21, Inc.
First posted: 2007-05-24
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later
timeFrame: 8 weeks
Secondary outcomes:
measure: Hunger and satiety between the lunch and dinner meal
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Stephen D Anton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: