- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03342313
Increasing in Chewing Number Reduces Energy Intake in Healthy Weight and Overweight Young Adults
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bangkok, Thailand, 10330
- Suwimol Sapwarobol
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- non-smoking
- eating breakfast regularly
- not allergic to any food
- no eating disorders
- weight stable over the past 3 months
Exclusion Criteria:
- have dental problem
- taking any medications or dietary supplements that may confound any study indicators
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: healthy weight
BMI (kg/m2) ≥ 18.5 and < 23
|
Sandwich as a breakfast for testing chewing activities.
|
|
Experimental: Overweight
BMI (kg/m2) ≥23 chewing 15 times and 50 times per bite
|
Sandwich as a breakfast for testing chewing activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
chewing times per bite
Time Frame: 2 months
|
chewing times per bite
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
energy intake
Time Frame: 2 months
|
chewing 15 and 50 times per bite on amount of food eaten
|
2 months
|
|
hunger, satiety, appetite
Time Frame: 2 months
|
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).
|
2 months
|
|
postprandial plasma glucose
Time Frame: at 0, 30, 60, 90, 120 and 180 min after eating
|
blood glucose after eating
|
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
|
plasma insulin after eating
|
at 0, 30, 60, 90, 120 and 180 min after eating
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chewing and energy intake
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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