Effects of Gum Chewing on Appetite and Digestion
This study has been completed.
Sponsor:
Purdue University
Collaborator:
Information provided by (Responsible Party):
Purdue University
ClinicalTrials.gov Identifier:
NCT01070212
First received: February 16, 2010
Last updated: April 18, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
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 Other: firm gum Other: no gum |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Effects of Gum Chewing on Appetite and Digestion |
Resource links provided by NLM:
Further study details as provided by Purdue University:
Primary Outcome Measures:
- Effects of mastication on appetite. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]Effects of varying chewing intensity on self-rated hunger, fullness, desire to eat and thirst.
Secondary Outcome Measures:
- Endocrine response [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Effects of varying chewing intensity on serum/plasma GLP-1, Ghrelin, CCK, Insulin.
- Blood chemistries [ Time Frame: 4 Hours ] [ Designated as safety issue: No ]Effects of varying chewing intensity on lipid profiles and glucose.
| Enrollment: | 60 |
| Study Start Date: | February 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
. 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).
|
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).
|
|
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
. 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).
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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:
-
Contacts and Locations More Information
No publications provided
| Responsible Party: | Purdue University |
| ClinicalTrials.gov Identifier: | NCT01070212 History of Changes |
| Other Study ID Numbers: | R01DK079913-2, R01DK079913, 0911008653 |
| Study First Received: | February 16, 2010 |
| Last Updated: | April 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Purdue University:
|
human, chewing, appetite, |
Additional relevant MeSH terms:
|
Acetaminophen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013