CClinicalTrials.gg
CompletedNCT01070212Updated Dec 15, 2023

Effects of Gum Chewing on Appetite and Digestion

An interventional study of soft gum and firm gum in 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 and It is Hypothesized That the Effects of Mastication Will be Less Evident in Obese Compared to Lean Individuals, sponsored by Purdue University. Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-15.

Sponsored by Purdue University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • 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

Keywords

  • human, chewing, appetite,
03

In context

Lead sponsor

Purdue University is the lead sponsor of 168 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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).

    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).

    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).

    Other: no gum

Interventions

  • Othersoft 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).

  • Otherfirm 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).

  • Otherno 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).

06

What researchers measure

Primary outcomes

  1. Effects of mastication on appetite.

    Effects of varying chewing intensity on self-rated hunger, fullness, desire to eat and thirst.

    Time frame: 12 hours

Secondary outcomes

  1. Endocrine response

    Effects of varying chewing intensity on serum/plasma GLP-1, Ghrelin, CCK, Insulin.

    Time frame: 4 hours

  2. Blood chemistries

    Effects of varying chewing intensity on lipid profiles and glucose.

    Time frame: 4 Hours

07

Study locations

2 sites
  • Purdue University
    West Lafayette, Indiana 17907, United States
  • Purdue University
    West Lafayette, Indiana 47907, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01070212
Lead sponsor
Purdue University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Richard Mattes (Distinguished Prof. Foods and Nutrition, Purdue University) — Principal investigator
First posted
Feb 17, 2010
Start date
Feb 2010
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Dec 15, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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