GUM: A Study of Chewing Gum, Snacking and Appetite

Sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology (Industry)

Overall Status

Completed

CT.gov ID

NCT01316991

Collaborator

Wm. Wrigley Jr. Company (Industry)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hunger	Dietary Supplement: Chewing Gum Dietary Supplement: No Gum	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Understanding the Role of Chewing Gum in Satiation, Satiety and Hunger Management

Actual Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Chewing gum Subject will chew gum at defined intervals	Dietary Supplement: Chewing Gum chewing gum will be provided Other Names: subject will chew gum
Placebo Comparator: No Gum No chewing gum will be provided to subject	Dietary Supplement: No Gum no chewing gum will be provided Other Names: subject will not chew gum

Arm

Intervention/Treatment

Active Comparator: Chewing gum

Subject will chew gum at defined intervals

Dietary Supplement: Chewing Gum

chewing gum will be provided

Other Names:

subject will chew gum

Placebo Comparator: No Gum

No chewing gum will be provided to subject

Dietary Supplement: No Gum

no chewing gum will be provided

Other Names:

subject will not chew gum

Outcome Measures

Primary Outcome Measures

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. [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.

Secondary Outcome Measures

To investigate the relationship of metabolic responses to gum-induced/enhanced satiety by evaluating changes in free-living food intake in adult women [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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