We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Gum Chewing on Appetite and Digestion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01070212
First Posted: February 17, 2010
Last Update Posted: May 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Richard Mattes, Purdue University
February 16, 2010
February 17, 2010
May 30, 2013
February 2010
January 2012   (Final data collection date for primary outcome measure)
Effects of mastication on appetite. [ Time Frame: 12 hours ]
Effects of varying chewing intensity on self-rated hunger, fullness, desire to eat and thirst.
Not Provided
Complete list of historical versions of study NCT01070212 on ClinicalTrials.gov Archive Site
  • Endocrine response [ Time Frame: 4 hours ]
    Effects of varying chewing intensity on serum/plasma GLP-1, Ghrelin, CCK, Insulin.
  • Blood chemistries [ Time Frame: 4 Hours ]
    Effects of varying chewing intensity on lipid profiles and glucose.
Not Provided
Not Provided
Not Provided
 
Effects of Gum Chewing on Appetite and Digestion
Effects of Gum Chewing on Appetite and Digestion
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • 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.
  • Other: 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).
  • Other: 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).
  • Other: 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).
  • 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).
    Intervention: Other: soft gum
  • 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).
    Intervention: Other: firm gum
  • 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).
    Intervention: Other: no gum
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2012
January 2012   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01070212
R01DK079913-2
R01DK079913 ( U.S. NIH Grant/Contract )
0911008653 ( Other Identifier: Purdue University )
No
Not Provided
Not Provided
Richard Mattes, Purdue University
Purdue University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Purdue University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
To Top