search
Back to results

Effect of Food Temperature and Diet Composition on Satiety, Satiety Hormones, Chewing Time and Neuronal Activity

Primary Purpose

Obesity, Overweight

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High Protein Meal at Cold Temperature
High Protein Meal at Warm Temperarute
High Protein Meal at Hot Temperature
High Carbohydrate Meal at Cold Temperature
High Carbohydrate Meal at Warm Temperature
High Carbohydrate Meal at Hot Temperature
High Fat Meal at Cold Temperature
High Fat Meal at Warm Temperature
High Fat Meal at Hot Temperature
Sponsored by
Khyber Medical University Peshawar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Overweight focused on measuring Satiety, Food Intake, Food Temperature, Food Composition, Gut Hormones, Satiety-related Hormones, Chewing time, Appetite, Satiety Score, EEG, Brain Waves, EMG, CCK, GLP-1, Insulin, Peptide YY, Ghrelin, high Protein meal, high Fat meal, High Carbohydrate meal, Chewing count, Alpha wave

Eligibility Criteria

25 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy individuals of age 25- 35 years BMI ranged between 18.5 and 24.9 Exclusion Criteria: Chronic diseases, diabetes, endocrine disorder, Any bariatric surgery that interfered with gastrointestinal functions, Smoking, Dieting, Pregnancy, lactation, Taking medication or supplements. Psychiatry illnesses or dental problems will be excluded. Females with the history of premenstrual syndrome will be excluded. Gastrointestinal Complications Following Special diets Food allergy to food used in the trial

Sites / Locations

  • Khyber Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

High Protein Meal with cold temperature

High Protein Meal with warm temperature

High Protein Meal with Hot temperature

High Carbohydrate Meal with cold temperature

High Carbohydrate Meal with warm temperature

High Carbohydrate Meal with hot temperature

High Fat Meal with cold temperature

High Fat Meal with warm temperature

High Fat Meal with hot temperature

Arm Description

Outcomes

Primary Outcome Measures

Hedonic 9-point
Hedonic 9-point scale for acceptability of meal in terms of appearance, texture, smell, flavor and temperate.
GLP-1
Glucagon like peptide-1
Chew Counting
Chew Counting was done while the test meal is consumed by the participant by EMG and video recording same time.
EEG
Pre-prandial baseline EEG was done and then immediately after when the food intake is finished and 1 hour post prandial. Alpha wave amplitude and frequency were noted.
CCK
Cholecystokinin
PYY
Peptide tyrosine tyrosine
Ghrelin
Human ghrelin
Glucose
Pre-prandial baseline glucose and then after food intake
Insulin
Pre-prandial baseline and after food intake
Serotonin
Pre-prandial baseline and after food intake

Secondary Outcome Measures

Remainder food intake
The food given to the subjects was weighed before serving. After the participants had finished their meals the serving dish with the left overs was weighed again with the kitchen weighing scale.
Satiety
Visual analog scale on a scale of 0 to 100 mm. High score indicate better and low score indicate worse outcome.

Full Information

First Posted
March 6, 2023
Last Updated
April 7, 2023
Sponsor
Khyber Medical University Peshawar
search

1. Study Identification

Unique Protocol Identification Number
NCT05822167
Brief Title
Effect of Food Temperature and Diet Composition on Satiety, Satiety Hormones, Chewing Time and Neuronal Activity
Official Title
Effect of Food Temperature and Diet Composition on Satiety, Satiety Hormones, Chewing Time and Neuronal Activity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khyber Medical University Peshawar

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
Obesity and its related illnesses have become serious health issues, obesity is today the fifth most common cause of death. Obesity rate has dramatically enhanced in both male and female, and across all ages. Food and energy intake during habitual meals, energy balance, energy expended during physical activity, all play an important role in management of weight. Lifestyle changes and nutritional strategies are emerging as the best line of treatment for obesity. The achievement of satiety along with, the reduction in dietary intake is the primary goal of nutritionists and food scientists. Appetite control can be defined by two terms; satiety and satiation. The interaction between appetite, food intake, and hormones secreted by the gastrointestinal tract, which are secreted in response to macronutrients like carbohydrates, fats and proteins are the satiety regulators. The gut hormones including glucagon like peptide 1(GLP1), cholecystokinin (CCK) are anorexigenic in action, cause slowing of meal digestion and reduce food intake thus inducing satiation and satiety. The CCK hormone plays a key role in delaying of stomach emptying by fundus relaxation and antral inhibition, ultimately causing major satiation. The incretin hormone GLP-1's main action is to stimulate insulin secretion, inhibit glucagon secretion, regulating postprandial glucose and provide negative feedback to the stomach thereby controlling appetite. Research is needed in meal properties and different diets which may affect gut-brain signaling and altering the mechanisms of gut hormonal secretion, thus further influencing appetite satiation and satiety scores. This knowledge can be utilized in energy expenditure and weight management. Serving temperatures alter perceived intensities, flavor and acceptances of food as well. Brain areas work in close association with the thermal perception and emotions. In neuroimaging studies neural changes have been when body is exposed to different temperatures either environmental or oral cavity. Temperature of food play an important role in the palatability and affective value of food and, consequently, in appetite regulation. Limited research has been done so far how food temperature is related to sensory perception and satiety Chewing and food texture also affect satiety and satiation. The oral processing, eating rate and physical forms of food i.e., solid versus liquid or semi-solid are all physiologically related to satiety and an individual's behavior to understand this oral sensory satiety effect, requires further studies. The number of chews has been studied showing an association between reduction in food intake with increasing number of chews. EEG is a noninvasive neuroimaging technique, helping in evaluating the cognitive part of food stimuli and food ingestion in relation to gut hormones. Sensory properties of previously identified as drivers of refreshing perception, enhance alpha and beta brain oscillations as observed in prior EEG studies. Many factors influence satiety including food composition, temperature, environment, last meal and preload. Limited literature is available about temperature of food and its influence on satiety. My study aims to find 1) the effect of temperature of high carbohydrate, high fat meal and high protein meal on the satiety scores, satiety-related hormones, EEG and EMG. 2. To find the effect of chewing time of food on the satiety scores, satiety- related hormones, EEG and EMG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Satiety, Food Intake, Food Temperature, Food Composition, Gut Hormones, Satiety-related Hormones, Chewing time, Appetite, Satiety Score, EEG, Brain Waves, EMG, CCK, GLP-1, Insulin, Peptide YY, Ghrelin, high Protein meal, high Fat meal, High Carbohydrate meal, Chewing count, Alpha wave

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
3 interventional Studies 9 arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Protein Meal with cold temperature
Arm Type
Experimental
Arm Title
High Protein Meal with warm temperature
Arm Type
Experimental
Arm Title
High Protein Meal with Hot temperature
Arm Type
Experimental
Arm Title
High Carbohydrate Meal with cold temperature
Arm Type
Experimental
Arm Title
High Carbohydrate Meal with warm temperature
Arm Type
Experimental
Arm Title
High Carbohydrate Meal with hot temperature
Arm Type
Experimental
Arm Title
High Fat Meal with cold temperature
Arm Type
Experimental
Arm Title
High Fat Meal with warm temperature
Arm Type
Experimental
Arm Title
High Fat Meal with hot temperature
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
High Protein Meal at Cold Temperature
Intervention Description
High Protein Meal providing 500kcal with 60% energy from protein, 30% fat, 10% carbohydrate. Cold meal will be served at 25 degree C and below.
Intervention Type
Other
Intervention Name(s)
High Protein Meal at Warm Temperarute
Intervention Description
High Protein Meal providing 500kcal with 60% energy from protein, 30% fat, 10% carbohydrate. Meal will be served at warm temperature i.e., between 40 degree C and 60 degree C.
Intervention Type
Other
Intervention Name(s)
High Protein Meal at Hot Temperature
Intervention Description
High Protein Meal providing 500kcal with 60% energy from protein, 30% fat, 10% carbohydrate. Meal will be served at hot temperature i.e., 60 degree C and above.
Intervention Type
Other
Intervention Name(s)
High Carbohydrate Meal at Cold Temperature
Intervention Description
High carbohydrate meal providing 500 kcal with 65% of energy from carbohydrates, 25% from proteins and 10% from fats. Cold meal will be served at 25 degree C and below.
Intervention Type
Other
Intervention Name(s)
High Carbohydrate Meal at Warm Temperature
Intervention Description
High carbohydrate meal providing 500 kcal with 65% of energy from carbohydrates, 25% from proteins and 10% from fats. Meal will be served at warm temperature i.e., between 40 degree C and 60 degree C.
Intervention Type
Other
Intervention Name(s)
High Carbohydrate Meal at Hot Temperature
Intervention Description
High carbohydrate meal providing 500 kcal with 65% of energy from carbohydrates, 25% from proteins and 10% from fats. Meal will be served at hot temperature i.e., 60 degree C and above.
Intervention Type
Other
Intervention Name(s)
High Fat Meal at Cold Temperature
Intervention Description
High fat meal will contain 60% fat, 30% protein, 10% carbohydrate. Cold meal will be served at 25 degree C and below.
Intervention Type
Other
Intervention Name(s)
High Fat Meal at Warm Temperature
Intervention Description
High fat meal will contain 60% fat, 30% protein, 10% carbohydrate. Meal will be served at warm temperature i.e., between 40 degree C and 60 degree C.
Intervention Type
Other
Intervention Name(s)
High Fat Meal at Hot Temperature
Intervention Description
High fat meal will contain 60% fat, 30% protein, 10% carbohydrate. Meal will be served at hot temperature i.e., 60 degree C and above.
Primary Outcome Measure Information:
Title
Hedonic 9-point
Description
Hedonic 9-point scale for acceptability of meal in terms of appearance, texture, smell, flavor and temperate.
Time Frame
30 minutes
Title
GLP-1
Description
Glucagon like peptide-1
Time Frame
Change from baseline till 4 hours
Title
Chew Counting
Description
Chew Counting was done while the test meal is consumed by the participant by EMG and video recording same time.
Time Frame
Up to 2 hours
Title
EEG
Description
Pre-prandial baseline EEG was done and then immediately after when the food intake is finished and 1 hour post prandial. Alpha wave amplitude and frequency were noted.
Time Frame
Change from baseline till 1 hour
Title
CCK
Description
Cholecystokinin
Time Frame
0 minutes, 30 minutes and 180 minutes
Title
PYY
Description
Peptide tyrosine tyrosine
Time Frame
Change from baseline to 180 minutes
Title
Ghrelin
Description
Human ghrelin
Time Frame
Change from baseline to 120 minutes
Title
Glucose
Description
Pre-prandial baseline glucose and then after food intake
Time Frame
Change from baseline to 120 minutes
Title
Insulin
Description
Pre-prandial baseline and after food intake
Time Frame
Change from baseline to 180 minutes
Title
Serotonin
Description
Pre-prandial baseline and after food intake
Time Frame
Change from baseline to 60 minutes
Secondary Outcome Measure Information:
Title
Remainder food intake
Description
The food given to the subjects was weighed before serving. After the participants had finished their meals the serving dish with the left overs was weighed again with the kitchen weighing scale.
Time Frame
Up to 24 hours
Title
Satiety
Description
Visual analog scale on a scale of 0 to 100 mm. High score indicate better and low score indicate worse outcome.
Time Frame
Change from baseline to 240 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy individuals of age 25- 35 years BMI ranged between 18.5 and 24.9 Exclusion Criteria: Chronic diseases, diabetes, endocrine disorder, Any bariatric surgery that interfered with gastrointestinal functions, Smoking, Dieting, Pregnancy, lactation, Taking medication or supplements. Psychiatry illnesses or dental problems will be excluded. Females with the history of premenstrual syndrome will be excluded. Gastrointestinal Complications Following Special diets Food allergy to food used in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Omar Malik, PhD
Phone
00923335196243
Email
omarmalik786@gmail.com
Facility Information:
Facility Name
Khyber Medical University
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Omar Malik, PhD
Phone
00923335196243
Email
omarmalik786@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr Omar Malik, PhD
First Name & Middle Initial & Last Name & Degree
Dr Bibi Hajira, PhD
First Name & Middle Initial & Last Name & Degree
Dr Naila Hamid, MPhil

12. IPD Sharing Statement

Citations:
PubMed Identifier
9846779
Citation
Rexrode KM, Carey VJ, Hennekens CH, Walters EE, Colditz GA, Stampfer MJ, Willett WC, Manson JE. Abdominal adiposity and coronary heart disease in women. JAMA. 1998 Dec 2;280(21):1843-8. doi: 10.1001/jama.280.21.1843.
Results Reference
background
PubMed Identifier
17124223
Citation
McMillan DC, Sattar N, McArdle CS. ABC of obesity. Obesity and cancer. BMJ. 2006 Nov 25;333(7578):1109-11. doi: 10.1136/bmj.39042.565035.BE1. No abstract available.
Results Reference
background
Citation
Chambers L, Mc Crickerd K, Yeomans M. R. Optimising foods for satiety.Trends Food Sci. Technol. 2015; 41: 149-160. https ://doi.org/10.1016/j.tifs.2014.10.007
Results Reference
background
Citation
Blundell J. E, De Graaf K , Finlayson G, Halford J. C, Hetherington M, KingN, & Stubbs J. Assessment Methods for Eating Behaviour and Weight-Related Problems: Measures, Theory and Research. 2009; 283-325 (Sage, Thousand Oaks).
Results Reference
background
PubMed Identifier
25241326
Citation
Camilleri M. Peripheral mechanisms in appetite regulation. Gastroenterology. 2015 May;148(6):1219-33. doi: 10.1053/j.gastro.2014.09.016. Epub 2014 Sep 21.
Results Reference
background
PubMed Identifier
23666746
Citation
van der Klaauw AA, Keogh JM, Henning E, Trowse VM, Dhillo WS, Ghatei MA, Farooqi IS. High protein intake stimulates postprandial GLP1 and PYY release. Obesity (Silver Spring). 2013 Aug;21(8):1602-7. doi: 10.1002/oby.20154. Epub 2013 May 13.
Results Reference
background
PubMed Identifier
15633135
Citation
Strader AD, Woods SC. Gastrointestinal hormones and food intake. Gastroenterology. 2005 Jan;128(1):175-91. doi: 10.1053/j.gastro.2004.10.043.
Results Reference
background
PubMed Identifier
26429068
Citation
Gibbons C, Finlayson G, Caudwell P, Webb DL, Hellstrom PM, Naslund E, Blundell JE. Postprandial profiles of CCK after high fat and high carbohydrate meals and the relationship to satiety in humans. Peptides. 2016 Mar;77:3-8. doi: 10.1016/j.peptides.2015.09.010. Epub 2015 Sep 30.
Results Reference
background
PubMed Identifier
11956351
Citation
Tanaka M, Nagashima K, McAllen RM, Kanosue K. Role of the medullary raphe in thermoregulatory vasomotor control in rats. J Physiol. 2002 Apr 15;540(Pt 2):657-64. doi: 10.1113/jphysiol.2001.012989.
Results Reference
background
PubMed Identifier
18468687
Citation
Rolls ET. The affective and cognitive processing of touch, oral texture, and temperature in the brain. Neurosci Biobehav Rev. 2010 Feb;34(2):237-45. doi: 10.1016/j.neubiorev.2008.03.010. Epub 2008 Apr 3.
Results Reference
background
PubMed Identifier
26188140
Citation
Miquel-Kergoat S, Azais-Braesco V, Burton-Freeman B, Hetherington MM. Effects of chewing on appetite, food intake and gut hormones: A systematic review and meta-analysis. Physiol Behav. 2015 Nov 1;151:88-96. doi: 10.1016/j.physbeh.2015.07.017. Epub 2015 Jul 15.
Results Reference
background
PubMed Identifier
24847856
Citation
Robinson E, Almiron-Roig E, Rutters F, de Graaf C, Forde CG, Tudur Smith C, Nolan SJ, Jebb SA. A systematic review and meta-analysis examining the effect of eating rate on energy intake and hunger. Am J Clin Nutr. 2014 Jul;100(1):123-51. doi: 10.3945/ajcn.113.081745. Epub 2014 May 21.
Results Reference
background
PubMed Identifier
26838265
Citation
Schlogl H, Horstmann A, Villringer A, Stumvoll M. Functional neuroimaging in obesity and the potential for development of novel treatments. Lancet Diabetes Endocrinol. 2016 Aug;4(8):695-705. doi: 10.1016/S2213-8587(15)00475-1. Epub 2016 Jan 30.
Results Reference
background
PubMed Identifier
12088700
Citation
Hallschmid M, Molle M, Fischer S, Born J. EEG synchronization upon reward in man. Clin Neurophysiol. 2002 Jul;113(7):1059-65. doi: 10.1016/s1388-2457(02)00142-6.
Results Reference
background

Learn more about this trial

Effect of Food Temperature and Diet Composition on Satiety, Satiety Hormones, Chewing Time and Neuronal Activity

We'll reach out to this number within 24 hrs