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OpenTrials
Completed

NCT Number: NCT01070212

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.

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Key information

Conditions

The Null Hypothesis is That Food Rheology Will Have no Effect on These Indices It is Hypothesized That the Effects of Mastication Will be Less Evident in Obese Compared to Lean Individuals The Alternate Hypothesis is That Increased Mechanical Stimulation Will Result in Stronger Satiation/Satiety and Reduced Energy Intake

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University, West Lafayette, Indiana, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

soft gum

Other

. 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).

firm gum

Other

. 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).

NO GUM

Other

. 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).

Primary outcomes

  1. Effects of mastication on appetite.

    Time frame: 12 hours

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

Secondary outcomes

  1. Endocrine response

    Time frame: 4 hours

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

  2. Blood chemistries

    Time frame: 4 Hours

    Effects of varying chewing intensity on lipid profiles and glucose.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2010
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.