HungerGUMNCT01316991
A Study of Chewing Gum, Snacking and Appetite
A study testing Chewing Gum and No Gum in people with Hunger, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hunger
- What is being tested?
- Chewing Gum and No Gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2010to 1 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females
- 18 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)
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Understanding the Role of Chewing Gum in Satiation, Satiety and Hunger Management
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.
Read more
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.
Read the detailed description
The study is a randomized, 2-arm, placebo-controlled, within-subjects crossover study to evaluate the satiety and metabolic response patterns of gum/no gum in relatively healthy weight and obese women.
The study will require one initial screening visit (1 hour) and 2 study visits. We are looking for healthy, non-smoking women older than 18 years of age with no significant medical history.
The initial screening visit will determine subject eligibility through height, weight and waist circumference measurements, vital signs, blood glucose test (finger prick) and completion of a series of surveys related to eating, health, exercise and mood.
If willing and eligible to participate, subjects will have 2 study visits. The lunch will be provided 4 hours after a intra-subject standardized breakfast (the same breakfast for each subject before each study visit). Upon arrival at each visit, subjects will have anthropometric measurements, vital signs upon blood glucose finger prick as well as assessment for compliance with breakfast protocol, subsequent fasting and adequate water intake.
Upon completion of pre-study procedures, a registered nurse will place a catheter (flexible tubing) in the subjects' arm during each study visit. A catheter is used so subjects are not stuck with a needle for every blood sample. Instead, the catheter is inserted using a needle, the needle is removed and the flexible plastic tubing remains the arm for the duration of the study day serving as a port for collecting blood samples at the specific time points
The initial blood draw will be collected (pre-lunch) then the lunch meal served. Subjects will have 20 minutes to finish the entire lunch meal. Thereafter, subjects will describe feelings of hunger, thirst and desire to eat every 30 minutes for 3 hours followed by blood draws.
At one of the 2 study visits, subjects will be provided chewing gum at which they will chew gum for 15 minutes leading up to the question set and blood draw.
A tray of snacks will be provided at 3 hours post-lunch and subjects may consume the snacks as desired. Lastly, a final set of questions will be answered followed by a blood draw at 4 hours post-lunch.
During the course of the study, subjects will be instructed to maintain their usual level of activity and a self-selected diet. Three day food records will be maintained throughout the course of the study.
Each study visit will last approximately 4 1/2 hours and subjects will be required to remain at the Clinical Nutrition Research Center on the IIT Campus for the duration of the visit.
- Conditions
- Hunger
- Being tested
- Chewing Gum, No Gum
- Keywords
- chewing gum, appetite, hunger, satiety, metabolic, nutrition, gut peptide hormones, psychological phenomena and processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing GumDietary supplement
Also called subject will chew gum
chewing gum will be provided
No GumDietary supplement
Also called subject will not chew gum
no chewing gum will be provided
| Study group | Role | What they receive |
|---|---|---|
| Chewing gum | Active comparator | Subject will chew gum at defined intervals Receives: Dietary Supplement: Chewing Gum |
| No Gum | Placebo comparator | No chewing gum will be provided to subject Receives: Dietary Supplement: No Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Blood draws will also be collected every 30 minutes post-lunch for 3 hours. One additional blood draw will be completed at 4 hours post-lunch.
Subjects will be asked to maintain a self-selected diet throughout the study period. Leading up to the study visits, subjects will measure and record all food intake using food intake scales provided. Subjects will also be asked to measure and record all food intake for the remainder of the study visit day.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study start1 Dec 2010
- Primary completion1 Sep 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HungerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wm. Wrigley Jr. Company
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, MS, PhD, Study director, National Center Food Safety and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316991
- Sponsor's protocol ID
- GUM 2010-066
- Acronym
- GUM
- Status last verified
- Aug 2021
- First submitted
- 15 Mar 2011
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26948161
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of Chewing Gum in Satiation, Satiety and Hunger Management
- ClinicalTrials.gov ID
- NCT01316991
- Acronym / sponsor ID
- GUM / GUM 2010-066
- Conditions
- Hunger
- Keywords
- chewing gum, appetite, hunger, satiety, metabolic, nutrition, gut peptide hormones, psychological phenomena and processes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Wm. Wrigley Jr. Company
- Study start
- 1 Dec 2010 (actual)
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a randomized, 2-arm, placebo-controlled, within-subjects crossover study to evaluate the satiety and metabolic response patterns of gum/no gum in relatively healthy weight and obese women.
The study will require one initial screening visit (1 hour) and 2 study visits. We are looking for healthy, non-smoking women older than 18 years of age with no significant medical history.
The initial screening visit will determine subject eligibility through height, weight and waist circumference measurements, vital signs, blood glucose test (finger prick) and completion of a series of surveys related to eating, health, exercise and mood.
If willing and eligible to participate, subjects will have 2 study visits. The lunch will be provided 4 hours after a intra-subject standardized breakfast (the same breakfast for each subject before each study visit). Upon arrival at each visit, subjects will have anthropometric measurements, vital signs upon blood glucose finger prick as well as assessment for compliance with breakfast protocol, subsequent fasting and adequate water intake.
Upon completion of pre-study procedures, a registered nurse will place a catheter (flexible tubing) in the subjects' arm during each study visit. A catheter is used so subjects are not stuck with a needle for every blood sample. Instead, the catheter is inserted using a needle, the needle is removed and the flexible plastic tubing remains the arm for the duration of the study day serving as a port for collecting blood samples at the specific time points
The initial blood draw will be collected (pre-lunch) then the lunch meal served. Subjects will have 20 minutes to finish the entire lunch meal. Thereafter, subjects will describe feelings of hunger, thirst and desire to eat every 30 minutes for 3 hours followed by blood draws.
At one of the 2 study visits, subjects will be provided chewing gum at which they will chew gum for 15 minutes leading up to the question set and blood draw.
A tray of snacks will be provided at 3 hours post-lunch and subjects may consume the snacks as desired. Lastly, a final set of questions will be answered followed by a blood draw at 4 hours post-lunch.
During the course of the study, subjects will be instructed to maintain their usual level of activity and a self-selected diet. Three day food records will be maintained throughout the course of the study.
Each study visit will last approximately 4 1/2 hours and subjects will be required to remain at the Clinical Nutrition Research Center on the IIT Campus for the duration of the visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing gum | Active comparator | Dietary Supplement: Chewing GumSubject will chew gum at defined intervals |
| No Gum | Placebo comparator | Dietary Supplement: No GumNo chewing gum will be provided to subject |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females
- 18 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing GumAlso: subject will chew gumchewing gum will be provided | Dietary supplement | Chewing gum |
| No GumAlso: subject will not chew gumno chewing gum will be provided | Dietary supplement | No Gum |
Primary outcome
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.
Time frame: 4 hour post prandial study
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.
1 secondary outcome
To investigate the relationship of metabolic responses to gum-induced/enhanced satiety by evaluating changes in free-living food intake in adult women
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Derived from this study: PubMed 26948161Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt Burton-Freeman, MS, PhD study director
National Center Food Safety and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing Gum and No Gum in people with Hunger, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4 hour post prandial study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021; AzTrials last refreshed its copy on 1 Nov 2026.