MasticationNCT03342313
Increasing in Chewing Number Reduces Energy Intake in Healthy Weight and Overweight Young Adults
A study testing Food - Sandwich in people with Mastication, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
A randomized cross-over design aims to investigate chewing activities between healthy vs. overweight and determine effects chewing times on energy intake and postprandial plasma glucose and insulin. Forty-one participants were allocated into lean and overweight groups according to BMI. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mastication
- What is being tested?
- Food - Sandwich
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteThailand
- Study dates
- 15 Mar 2015to 4 Feb 2016
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smoking
- eating breakfast regularly
- not allergic to any food
- no eating disorders
- weight stable over the past 3 months
Who cannot join
- have dental problem
- taking any medications or dietary supplements that may confound any study indicators
Trial locations and contacts
1 site in 1 country.
About this study
A randomized cross-over design aims to investigate chewing activities between healthy vs. overweight and determine effects chewing times on energy intake and postprandial plasma glucose and insulin. Forty-one participants were allocated into lean and overweight groups according to BMI. Phase I, Bite size (g/bite), bite rate (bites/min), chewing frequency (chews/min), and chews (chews/g food) were recorded after a sandwich breakfast. Phase II, gram of sandwich eaten ad libitum after 15 and 50 chew per bite (number from phase I) were recorded. Postprandial plasma glucose and insulin were examined at 0 (baseline), 30, 60, 90, 120 and 180 min.
Read the detailed description
Forty-one eligible participants were divided into 2 groups; lean and overweight according to their BMI [lean BMI (kg/m2) ≥ 18.5 and < 23, overweight BMI ≥23]
Phase I: investigate the differences of chewing activities between healthy weight and overweight participants.
The day before the clinic visit, participants were requested to consume only portion control of fried rice with egg for their dinner at 6 -7 pm. No other foods or drinks were allowed after provided dinner. The next morning, participants arrived at the clinic between 7-8 am after a 12 hours overnight fast and a 24 hours period without exercise. Sandwich was served with 300 ml. of water for breakfast ad libitum. Foods consumed were recorded. A digital camera recorded each participants chewing activities including bite size (g/bite); the ratio of food weight to bite number, bite rate (bites/min); the ratio of bite number to meal time, chewing frequency (chews/min); the ratio of chews to meal time, chews (chews/g food); the ratio of chews to meal weight.
Phase II: investigate the effects 15 chews and 50 chews on energy intake, hunger, satiety, appetite, postprandial plasma glucose and insulin in both healthy weight and overweight participants Participants were allocated into 2 groups of a 15 chews and 50 chews per bites with 2 weeks of wash-out period. The day before the clinic visit, participants were requested to consume only portion control of fried rice with egg for their dinner at 6 -7 pm. No other foods or drinks were allowed after provided dinner in order to prevent confounding factors of previous food consumption. On the next day, participants arrived at the clinic between 7-8 am after a 12 hours overnight fast and a 24 hours period without exercise. At clinic visit, baseline characteristics including anthropometry, hunger, satiety, appetite, and plasma glucose and insulin concentrations were collected before breakfast was served. Participant was requested to rate their hunger, satiety and appetite using a visual analogue scale (VAS) questionnaire.
After collecting baseline indicators, participants were served an ad libitum sandwich and 300 ml water for breakfast. Participants had to finish their breakfast within 20 min after first bite. VAS questionnaire and blood samples of postprandial glucose and insulin were examined at 0 (baseline) 30, 60, 90, 120 and 180 min after test meal. Blood samples was collected from indwelling catheters at mentioned time points.
- Conditions
- Mastication
- Being tested
- Food - Sandwich
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food - SandwichOther
Sandwich as a breakfast for testing chewing activities.
| Study group | Role | What they receive |
|---|---|---|
| healthy weight | Experimental | BMI (kg/m2) ≥ 18.5 and < 23 Receives: Other: Food - Sandwich |
| Overweight | Experimental | BMI (kg/m2) ≥23 chewing 15 times and 50 times per bite Receives: Other: Food - Sandwich |
What is being measured
The primary outcome is the main question the study is designed to answer.
chewing times per bite
chewing times per bite
Measured: 2 months
Secondary outcomes (4)
energy intake
chewing 15 and 50 times per bite on amount of food eaten
Measured: 2 months
hunger, satiety, appetite
a paper- based visual analogue scale (VAS) questionnaire of hunger, satiety, appetite. Each VAS questionnaire contains 100 millimeters in length and labels from not at all (scores 0) to extremely (scores10).
Measured: 2 months
postprandial plasma glucose
blood glucose after eating
Measured: at 0, 30, 60, 90, 120 and 180 min after eating
postprandial plasma insulin
plasma insulin after eating
Measured: at 0, 30, 60, 90, 120 and 180 min after eating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start15 Mar 2015
- Primary completion18 Aug 2015
- Study completion4 Feb 2016
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 MasticationStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross-over design
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwimol Sapwarobol, Chulalongkorn University
- Investigators
- suwimol sapwarobol, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342313
- Sponsor's protocol ID
- Chewing and energy intake
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Zhang N, Hu L, Li Z, Li R, Li C, Wang S. Improvement in chewing activity reduces energy intake in one meal and modulates plasma gut hormone concentrations in obese and lean young Chinese men. Am J Clin Nutr. 2011 Sep;94(3):709-16. doi: 10.3945/ajcn.111.015164. Epub 2011 Jul 20.
PubMed 21775556
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing in Chewing Number Reduces Energy Intake in Healthy Weight and Overweight Young Adults
- ClinicalTrials.gov ID
- NCT03342313
- Acronym / sponsor ID
- Chewing and energy intake
- Conditions
- Mastication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 15 Mar 2015 (actual)
- Primary completion
- 18 Aug 2015 (actual)
- Study completion
- 4 Feb 2016 (actual)
- First posted
- 14 Nov 2017 (actual)
- 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.
A randomized cross-over design aims to investigate chewing activities between healthy vs. overweight and determine effects chewing times on energy intake and postprandial plasma glucose and insulin. Forty-one participants were allocated into lean and overweight groups according to BMI. Phase I, Bite size (g/bite), bite rate (bites/min), chewing frequency (chews/min), and chews (chews/g food) were recorded after a sandwich breakfast. Phase II, gram of sandwich eaten ad libitum after 15 and 50 chew per bite (number from phase I) were recorded. Postprandial plasma glucose and insulin were examined at 0 (baseline), 30, 60, 90, 120 and 180 min.
Detailed description
Forty-one eligible participants were divided into 2 groups; lean and overweight according to their BMI [lean BMI (kg/m2) ≥ 18.5 and < 23, overweight BMI ≥23]
Phase I: investigate the differences of chewing activities between healthy weight and overweight participants.
The day before the clinic visit, participants were requested to consume only portion control of fried rice with egg for their dinner at 6 -7 pm. No other foods or drinks were allowed after provided dinner. The next morning, participants arrived at the clinic between 7-8 am after a 12 hours overnight fast and a 24 hours period without exercise. Sandwich was served with 300 ml. of water for breakfast ad libitum. Foods consumed were recorded. A digital camera recorded each participants chewing activities including bite size (g/bite); the ratio of food weight to bite number, bite rate (bites/min); the ratio of bite number to meal time, chewing frequency (chews/min); the ratio of chews to meal time, chews (chews/g food); the ratio of chews to meal weight.
Phase II: investigate the effects 15 chews and 50 chews on energy intake, hunger, satiety, appetite, postprandial plasma glucose and insulin in both healthy weight and overweight participants Participants were allocated into 2 groups of a 15 chews and 50 chews per bites with 2 weeks of wash-out period. The day before the clinic visit, participants were requested to consume only portion control of fried rice with egg for their dinner at 6 -7 pm. No other foods or drinks were allowed after provided dinner in order to prevent confounding factors of previous food consumption. On the next day, participants arrived at the clinic between 7-8 am after a 12 hours overnight fast and a 24 hours period without exercise. At clinic visit, baseline characteristics including anthropometry, hunger, satiety, appetite, and plasma glucose and insulin concentrations were collected before breakfast was served. Participant was requested to rate their hunger, satiety and appetite using a visual analogue scale (VAS) questionnaire.
After collecting baseline indicators, participants were served an ad libitum sandwich and 300 ml water for breakfast. Participants had to finish their breakfast within 20 min after first bite. VAS questionnaire and blood samples of postprandial glucose and insulin were examined at 0 (baseline) 30, 60, 90, 120 and 180 min after test meal. Blood samples was collected from indwelling catheters at mentioned time points.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cross-over design
| Arm | Type | Receives |
|---|---|---|
| healthy weight | Experimental | Other: Food - SandwichBMI (kg/m2) ≥ 18.5 and < 23 |
| Overweight | Experimental | Other: Food - SandwichBMI (kg/m2) ≥23 chewing 15 times and 50 times per bite |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- non-smoking
- eating breakfast regularly
- not allergic to any food
- no eating disorders
- weight stable over the past 3 months
Key exclusion criteria (2 listed)
- have dental problem
- taking any medications or dietary supplements that may confound any study indicators
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 |
|---|---|---|
| Food - SandwichSandwich as a breakfast for testing chewing activities. | Other | Overweight, healthy weight |
Primary outcome
chewing times per bite
Time frame: 2 months
chewing times per bite
4 secondary outcomes
energy intake
Time frame: 2 months
hunger, satiety, appetite
Time frame: 2 months
postprandial plasma glucose
Time frame: at 0, 30, 60, 90, 120 and 180 min after eating
postprandial plasma insulin
Time frame: at 0, 30, 60, 90, 120 and 180 min after eating
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 14 Nov 2017.
- Background: PubMed 21775556Li J, Zhang N, Hu L, Li Z, Li R, Li C, Wang S. Improvement in chewing activity reduces energy intake in one meal and modulates plasma gut hormone concentrations in obese and lean young Chinese men. Am J Clin Nutr. 2011 Sep;94(3):709-16. doi: 10.3945/ajcn.111.015164. Epub 2011 Jul 20.
- 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.
suwimol sapwarobol principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food - Sandwich in people with Mastication, run by Chulalongkorn University at 1 site in Thailand.
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 5 inclusion and 2 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 14 Nov 2017. 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 Thailand. 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. 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?
chewing times per bite (time frame: 2 months). 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 NCT03342313, 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 14 Nov 2017.