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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03342313
Other study ID # Chewing and energy intake
Secondary ID
Status Completed
Phase N/A
First received November 10, 2017
Last updated November 13, 2017
Start date March 15, 2015
Est. completion date February 4, 2016

Study information

Verified date November 2017
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date February 4, 2016
Est. primary completion date August 18, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Food - Sandwich
Sandwich as a breakfast for testing chewing activities.

Locations

Country Name City State
Thailand Suwimol Sapwarobol Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary chewing times per bite chewing times per bite 2 months
Secondary energy intake chewing 15 and 50 times per bite on amount of food eaten 2 months
Secondary 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). 2 months
Secondary postprandial plasma glucose blood glucose after eating at 0, 30, 60, 90, 120 and 180 min after eating
Secondary postprandial plasma insulin plasma insulin after eating at 0, 30, 60, 90, 120 and 180 min after eating
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