- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01070212
Effects of Gum Chewing on Appetite and Digestion
December 11, 2023 updated by: Richard Mattes, Purdue University
One obvious property difference between energy-yielding beverages and solid foods is the oral mechanical processing required to prepare the two food forms for swallowing.
Considerable human data are consistent with a contribution of mechanical stimulation to appetite suppression.
However, no study has isolated this property and assessed its influence on ingestive behavior in humans.
This is the aim of the present study.
The null hypothesis is that food rheology will have no effect on these indices.
The alternate hypothesis is that increased mechanical stimulation will result in stronger satiation/satiety and reduced energy intake.
Further, it is hypothesized that the effects of mastication will be less evident in obese compared to lean individuals.
Study Overview
Status
Completed
Conditions
- The Null Hypothesis is That Food Rheology Will Have no Effect on These Indices
- The Alternate Hypothesis is That Increased Mechanical Stimulation Will Result in Stronger Satiation/Satiety and Reduced Energy Intake
- It is Hypothesized That the Effects of Mastication Will be Less Evident in Obese Compared to Lean Individuals
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
West Lafayette, Indiana, United States, 17907
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- body mass index 18 -25 or 30-35 kg/ m2 good health not initiating or terminating the use of medications reported to affect appetite or body weight during the proposed study period stable activity level (no deviation > 1X/wk @ 30 min/session) no eating disorder (score <20 of the Eating Attitude Test (EAT-26) no allergies to test foods. not glucose intolerant or diabetic (based on fasting blood glucose between 70-99mg/dl (3.9-5.5mmol/l as recommended by the American Diabetes Association.) no history of GI pathology and self-reported consumer of breakfast and lunch.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: soft gum
. Participants will either chew nothing or chew one of the two gum varieties (flavorless soft or hard) at a constant rate (determined by a metronome) for 15 minutes while sipping apple juice through a straw.
Appetite will be measured continuously via a slide potentiometer attached to a 100mm gLMS scale.
The juice will provide 10% of the participants estimated daily energy requirement (i.e., equal to 1-2 servings of most commercial snacks).
It will also contain 10g of lactulose (a soluble, non-absorbable carbohydrate used to assess gastric transit time via analyses of breath hydrogen) and acetaminophen (a marker for gastric emptying).
|
. Participants will either chew nothing or chew one of the two gum varieties (flavorless soft or hard) at a constant rate (determined by a metronome) for 15 minutes while sipping apple juice through a straw.
Appetite will be measured continuously via a slide potentiometer attached to a 100mm gLMS scale.
The juice will provide 10% of the participants estimated daily energy requirement (i.e., equal to 1-2 servings of most commercial snacks).
It will also contain 10g of lactulose (a soluble, non-absorbable carbohydrate used to assess gastric transit time via analyses of breath hydrogen) and acetaminophen (a marker for gastric emptying).
|
Experimental: firm gum
. Participants will either chew nothing or chew one of the two gum varieties (flavorless soft or hard) at a constant rate (determined by a metronome) for 15 minutes while sipping apple juice through a straw.
Appetite will be measured continuously via a slide potentiometer attached to a 100mm gLMS scale.
The juice will provide 10% of the participants estimated daily energy requirement (i.e., equal to 1-2 servings of most commercial snacks).
It will also contain 10g of lactulose (a soluble, non-absorbable carbohydrate used to assess gastric transit time via analyses of breath hydrogen) and acetaminophen (a marker for gastric emptying).
|
. Participants will either chew nothing or chew one of the two gum varieties (flavorless soft or hard) at a constant rate (determined by a metronome) for 15 minutes while sipping apple juice through a straw.
Appetite will be measured continuously via a slide potentiometer attached to a 100mm gLMS scale.
The juice will provide 10% of the participants estimated daily energy requirement (i.e., equal to 1-2 servings of most commercial snacks).
It will also contain 10g of lactulose (a soluble, non-absorbable carbohydrate used to assess gastric transit time via analyses of breath hydrogen) and acetaminophen (a marker for gastric emptying).
|
Experimental: no gum
. Participants will either chew nothing or chew one of the two gum varieties (flavorless soft or hard) at a constant rate (determined by a metronome) for 15 minutes while sipping apple juice through a straw.
Appetite will be measured continuously via a slide potentiometer attached to a 100mm gLMS scale.
The juice will provide 10% of the participants estimated daily energy requirement (i.e., equal to 1-2 servings of most commercial snacks).
It will also contain 10g of lactulose (a soluble, non-absorbable carbohydrate used to assess gastric transit time via analyses of breath hydrogen) and acetaminophen (a marker for gastric emptying).
|
. Participants will either chew nothing or chew one of the two gum varieties (flavorless soft or hard) at a constant rate (determined by a metronome) for 15 minutes while sipping apple juice through a straw.
Appetite will be measured continuously via a slide potentiometer attached to a 100mm gLMS scale.
The juice will provide 10% of the participants estimated daily energy requirement (i.e., equal to 1-2 servings of most commercial snacks).
It will also contain 10g of lactulose (a soluble, non-absorbable carbohydrate used to assess gastric transit time via analyses of breath hydrogen) and acetaminophen (a marker for gastric emptying).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of mastication on appetite.
Time Frame: 12 hours
|
Effects of varying chewing intensity on self-rated hunger, fullness, desire to eat and thirst.
|
12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endocrine response
Time Frame: 4 hours
|
Effects of varying chewing intensity on serum/plasma GLP-1, Ghrelin, CCK, Insulin.
|
4 hours
|
Blood chemistries
Time Frame: 4 Hours
|
Effects of varying chewing intensity on lipid profiles and glucose.
|
4 Hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
February 16, 2010
First Submitted That Met QC Criteria
February 16, 2010
First Posted (Estimated)
February 17, 2010
Study Record Updates
Last Update Posted (Estimated)
December 15, 2023
Last Update Submitted That Met QC Criteria
December 11, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01DK079913-2
- R01DK079913 (U.S. NIH Grant/Contract)
- 0911008653 (Registry Identifier: Purdue University)
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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