A Study of Chewing Gum, Snacking and Appetite

NCT01316991 | Completed

• 1 other identifier: GUM 2010-066
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators are interested in learning how appetite responds after chewing gum. In this research study subjects will be asked to eat a lunch meal provided at our Center. After eating the lunch meal, subjects will answer questions describing their feelings of hunger, thirst and desire to eat every 30 minutes for 3 hours. Blood will be drawn throughout the study period to determine how chewing gum impacts certain hormones released from your intestine after eating and therefore how they influence your appetite. Blood draws will be done every 30 minutes for 3 hours. At only one of the two study visits, subjects will chew gum during specific times. One study visit will not include chewing gum. After three hours, there will be a snack to eat as much as desired followed by one more set of questions and blood draw. All study visits will take approximately 4 ½ hours.

Conditions

Hunger

Keywords

chewing gum; appetite; hunger; satiety; metabolic; nutrition; gut peptide hormones; psychological phenomena and processes

Outcome Measures

Primary Outcomes (1)

• To characterize the subjective and metabolic satiety response pattern to chewing gum vs. no chewing gum on subjective satiety and subsequent second meal intake in adult women.

  Chewing gum will be provided throughout the 4 hour post-prandial study at defined intervals at one of the two study visits. Feelings of hunger, fullness and desire to eat will be measured by the subject every 30 minutes post-lunch for 3 hours. Blood draws will also be collected every 30 minutes post-lunch for 3 hours. At 3 hours, a snack tray will be provided and subject will be instructed to consume as desired. One additional sent of questions and blood draw will be completed at 4 hours post-lunch.

  4 hour post prandial study

Secondary Outcomes (1)

• To investigate the relationship of metabolic responses to gum-induced/enhanced satiety by evaluating changes in free-living food intake in adult women

  2 days

Study Arms (2)

Chewing gum

ACTIVE COMPARATOR

Subject will chew gum at defined intervals

Dietary Supplement: Chewing Gum

No Gum

PLACEBO COMPARATOR

No chewing gum will be provided to subject

Dietary Supplement: No Gum

Interventions

Chewing Gum DIETARY_SUPPLEMENT

chewing gum will be provided

Also known as: subject will chew gum

Chewing gum

No Gum DIETARY_SUPPLEMENT

no chewing gum will be provided

Also known as: subject will not chew gum

No Gum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females
• years of age and older
• Healthy weight: BMI between 18.5 and 24.9 kg/m2, inclusive
• Obese: BMI between 30 - 38 kg/m2, inclusive
• No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
• Unrestrained eater (score \< 10 on the Three Factor Eating Questionnaire)

You may not qualify if:

• Pregnant and/or lactating or planning for pregnancy
• Allergies or intolerances to foods consumed in the study
• Fasting blood glucose \> 110 mg/dL. Subjects identified with elevated fasting blood glucose levels will be will be advised to contact their primary care physician for appropriate follow-up care.
• Taking over the counter supplements that may interfere with the study procedures or endpoints
• Taking prescription medications that may interfere with study procedures or endpoints (medications that affect appetite, unstable dose of hormones \<6 months)
• Subjects with unusual dietary habits (e.g. pica)
• Actively losing weight or trying to lose weight (unstable body weight fluctuations of \> 5 kg in a 60 day period)
• Excessive exercisers or trained athletes
• Addicted to drugs and/or alcohol
• Medically documented psychiatric or neurological disturbances
• Smoker (past smoker may be allowed if cessation is \> 2 years)

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• Wm. Wrigley Jr. Company: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

• Park E, Edirisinghe I, Inui T, Kergoat S, Kelley M, Burton-Freeman B. Short-term effects of chewing gum on satiety and afternoon snack intake in healthy weight and obese women. Physiol Behav. 2016 May 15;159:64-71. doi: 10.1016/j.physbeh.2016.03.002. Epub 2016 Mar 3.

  PMID: 26948161 DERIVED

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Britt Burton-Freeman, MS, PhD

  National Center Food Safety and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: December 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)