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

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



Sponsors


Source

Chulalongkorn University

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Completed

Start Date

2015-03-15

Completion Date

2016-02-04

Primary Completion Date

2015-08-18

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

chewing times per bite
2 months

Secondary Outcome

Measure

Time Frame

energy intake
2 months
hunger, satiety, appetite
2 months
postprandial plasma glucose
at 0, 30, 60, 90, 120 and 180 min after eating
postprandial plasma insulin
at 0, 30, 60, 90, 120 and 180 min after eating

Enrollment

41

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

Sandwich as a breakfast for testing chewing activities.

Arm Group Label

healthy weight

Overweight



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

Gender

All

Minimum Age

18 Years

Maximum Age

50 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

suwimol sapwarobol
Principal Investigator
Chulalongkorn University

Location

Facility

Suwimol Sapwarobol
Bangkok 10330 Thailand

Location Countries

Country

Thailand


Verification Date

2017-11-01

Lastchanged Date

2017-11-13

Firstreceived Date

2017-11-10

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Chulalongkorn University

Investigator Full Name

Suwimol Sapwarobol

Investigator Title

Assistant Professor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

healthy weight

Arm Group Type

Experimental

Description

BMI (kg/m2) ≥ 18.5 and < 23


Arm Group Label

Overweight

Arm Group Type

Experimental

Description

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



Firstreceived Results Date

N/A

Reference

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.

PMID

21775556


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Crossover Assignment

Intervention Model Description

Randomized cross-over design

Primary Purpose

Health Services Research

Masking

None (Open Label)


Study First Submitted

November 10, 2017

Study First Submitted Qc

November 13, 2017

Study First Posted

November 14, 2017

Last Update Submitted

November 13, 2017

Last Update Submitted Qc

November 13, 2017

Last Update Posted

November 14, 2017


ClinicalTrials.gov processed this data on November 14, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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