- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01316991
A Study of Chewing Gum, Snacking and Appetite (GUM)
Understanding the Role of Chewing Gum in Satiation, Satiety and Hunger Management
Investigators are interested in learning how appetite responds after chewing gum.
In this research study subjects will be asked to eat a lunch meal provided at our Center. After eating the lunch meal, subjects will answer questions describing their feelings of hunger, thirst and desire to eat every 30 minutes for 3 hours.
Blood will be drawn throughout the study period to determine how chewing gum impacts certain hormones released from your intestine after eating and therefore how they influence your appetite. Blood draws will be done every 30 minutes for 3 hours. At only one of the two study visits, subjects will chew gum during specific times. One study visit will not include chewing gum.
After three hours, there will be a snack to eat as much as desired followed by one more set of questions and blood draw.
All study visits will take approximately 4 ½ hours.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a randomized, 2-arm, placebo-controlled, within-subjects crossover study to evaluate the satiety and metabolic response patterns of gum/no gum in relatively healthy weight and obese women.
The study will require one initial screening visit (1 hour) and 2 study visits. We are looking for healthy, non-smoking women older than 18 years of age with no significant medical history.
The initial screening visit will determine subject eligibility through height, weight and waist circumference measurements, vital signs, blood glucose test (finger prick) and completion of a series of surveys related to eating, health, exercise and mood.
If willing and eligible to participate, subjects will have 2 study visits. The lunch will be provided 4 hours after a intra-subject standardized breakfast (the same breakfast for each subject before each study visit). Upon arrival at each visit, subjects will have anthropometric measurements, vital signs upon blood glucose finger prick as well as assessment for compliance with breakfast protocol, subsequent fasting and adequate water intake.
Upon completion of pre-study procedures, a registered nurse will place a catheter (flexible tubing) in the subjects' arm during each study visit. A catheter is used so subjects are not stuck with a needle for every blood sample. Instead, the catheter is inserted using a needle, the needle is removed and the flexible plastic tubing remains the arm for the duration of the study day serving as a port for collecting blood samples at the specific time points
The initial blood draw will be collected (pre-lunch) then the lunch meal served. Subjects will have 20 minutes to finish the entire lunch meal. Thereafter, subjects will describe feelings of hunger, thirst and desire to eat every 30 minutes for 3 hours followed by blood draws.
At one of the 2 study visits, subjects will be provided chewing gum at which they will chew gum for 15 minutes leading up to the question set and blood draw.
A tray of snacks will be provided at 3 hours post-lunch and subjects may consume the snacks as desired. Lastly, a final set of questions will be answered followed by a blood draw at 4 hours post-lunch.
During the course of the study, subjects will be instructed to maintain their usual level of activity and a self-selected diet. Three day food records will be maintained throughout the course of the study.
Each study visit will last approximately 4 1/2 hours and subjects will be required to remain at the Clinical Nutrition Research Center on the IIT Campus for the duration of the visit.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60616
- Clinical Nutrition Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Females
- 18 years of age and older
- Healthy weight: BMI between 18.5 and 24.9 kg/m2, inclusive
- Obese: BMI between 30 - 38 kg/m2, inclusive
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Unrestrained eater (score < 10 on the Three Factor Eating Questionnaire)
Exclusion Criteria:
- Pregnant and/or lactating or planning for pregnancy
- Allergies or intolerances to foods consumed in the study
- Fasting blood glucose > 110 mg/dL. Subjects identified with elevated fasting blood glucose levels will be will be advised to contact their primary care physician for appropriate follow-up care.
- Taking over the counter supplements that may interfere with the study procedures or endpoints
- Taking prescription medications that may interfere with study procedures or endpoints (medications that affect appetite, unstable dose of hormones <6 months)
- Subjects with unusual dietary habits (e.g. pica)
- Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg in a 60 day period)
- Excessive exercisers or trained athletes
- Addicted to drugs and/or alcohol
- Medically documented psychiatric or neurological disturbances
- Smoker (past smoker may be allowed if cessation is > 2 years)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Chewing gum
Subject will chew gum at defined intervals
|
chewing gum will be provided
Other Names:
|
Placebo Comparator: No Gum
No chewing gum will be provided to subject
|
no chewing gum will be provided
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To characterize the subjective and metabolic satiety response pattern to chewing gum vs. no chewing gum on subjective satiety and subsequent second meal intake in adult women.
Time Frame: 4 hour post prandial study
|
Chewing gum will be provided throughout the 4 hour post-prandial study at defined intervals at one of the two study visits. Feelings of hunger, fullness and desire to eat will be measured by the subject every 30 minutes post-lunch for 3 hours. Blood draws will also be collected every 30 minutes post-lunch for 3 hours. At 3 hours, a snack tray will be provided and subject will be instructed to consume as desired. One additional sent of questions and blood draw will be completed at 4 hours post-lunch. |
4 hour post prandial study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To investigate the relationship of metabolic responses to gum-induced/enhanced satiety by evaluating changes in free-living food intake in adult women
Time Frame: 2 days
|
Blood draws will also be collected every 30 minutes post-lunch for 3 hours. One additional blood draw will be completed at 4 hours post-lunch. Subjects will be asked to maintain a self-selected diet throughout the study period. Leading up to the study visits, subjects will measure and record all food intake using food intake scales provided. Subjects will also be asked to measure and record all food intake for the remainder of the study visit day. |
2 days
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Britt Burton-Freeman, MS, PhD, National Center Food Safety and Technology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GUM 2010-066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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