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Increasing in Chewing Number Reduces Energy Intake in Healthy Weight and Overweight Young Adults

Primary Purpose

Mastication

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Food - Sandwich
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mastication

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Suwimol Sapwarobol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

healthy weight

Overweight

Arm Description

BMI (kg/m2) ≥ 18.5 and < 23

BMI (kg/m2) ≥23 chewing 15 times and 50 times per bite

Outcomes

Primary Outcome Measures

chewing times per bite
chewing times per bite

Secondary Outcome Measures

energy intake
chewing 15 and 50 times per bite on amount of food eaten
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).
postprandial plasma glucose
blood glucose after eating
postprandial plasma insulin
plasma insulin after eating

Full Information

First Posted
November 10, 2017
Last Updated
November 13, 2017
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT03342313
Brief Title
Increasing in Chewing Number Reduces Energy Intake in Healthy Weight and Overweight Young Adults
Official Title
Increasing in Chewing Number Reduces Energy Intake in Healthy Weight and Overweight Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 15, 2015 (Actual)
Primary Completion Date
August 18, 2015 (Actual)
Study Completion Date
February 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastication

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized cross-over design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy weight
Arm Type
Experimental
Arm Description
BMI (kg/m2) ≥ 18.5 and < 23
Arm Title
Overweight
Arm Type
Experimental
Arm Description
BMI (kg/m2) ≥23 chewing 15 times and 50 times per bite
Intervention Type
Other
Intervention Name(s)
Food - Sandwich
Intervention Description
Sandwich as a breakfast for testing chewing activities.
Primary Outcome Measure Information:
Title
chewing times per bite
Description
chewing times per bite
Time Frame
2 months
Secondary Outcome Measure Information:
Title
energy intake
Description
chewing 15 and 50 times per bite on amount of food eaten
Time Frame
2 months
Title
hunger, satiety, appetite
Description
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).
Time Frame
2 months
Title
postprandial plasma glucose
Description
blood glucose after eating
Time Frame
at 0, 30, 60, 90, 120 and 180 min after eating
Title
postprandial plasma insulin
Description
plasma insulin after eating
Time Frame
at 0, 30, 60, 90, 120 and 180 min after eating

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
suwimol sapwarobol
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suwimol Sapwarobol
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21775556
Citation
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.
Results Reference
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Increasing in Chewing Number Reduces Energy Intake in Healthy Weight and Overweight Young Adults

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