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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05822167
Other study ID # ASRB001725/EF/IBMS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2023
Est. completion date August 28, 2023

Study information

Verified date May 2024
Source Khyber Medical University Peshawar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date August 28, 2023
Est. primary completion date August 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High Protein Meal at Cold Temperature
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.
High Protein Meal at Warm Temperarute
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.
High Protein Meal at Hot Temperature
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.
High Carbohydrate Meal at Cold Temperature
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.
High Carbohydrate Meal at Warm Temperature
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.
High Carbohydrate Meal at Hot Temperature
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.
High Fat Meal at Cold Temperature
High fat meal will contain 60% fat, 30% protein, 10% carbohydrate. Cold meal will be served at 25 degree C and below.
High Fat Meal at Warm Temperature
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.
High Fat Meal at Hot Temperature
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.

Locations

Country Name City State
Pakistan Khyber Medical University Peshawar KPK

Sponsors (1)

Lead Sponsor Collaborator
Khyber Medical University Peshawar

Country where clinical trial is conducted

Pakistan, 

References & Publications (14)

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).

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. — View 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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Hedonic 9-point Hedonic 9-point scale for acceptability of meal in terms of appearance, texture, smell, flavor and temperate. 30 minutes
Primary GLP-1 Glucagon like peptide-1 Change from baseline till 4 hours
Primary Chew Counting Chew Counting was done while the test meal is consumed by the participant by EMG and video recording same time. Up to 2 hours
Primary 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. Change from baseline till 1 hour
Primary CCK Cholecystokinin 0 minutes, 30 minutes and 180 minutes
Primary PYY Peptide tyrosine tyrosine Change from baseline to 180 minutes
Primary Ghrelin Human ghrelin Change from baseline to 120 minutes
Primary Glucose Pre-prandial baseline glucose and then after food intake Change from baseline to 120 minutes
Primary Insulin Pre-prandial baseline and after food intake Change from baseline to 180 minutes
Primary Serotonin Pre-prandial baseline and after food intake Change from baseline to 60 minutes
Secondary 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. Up to 24 hours
Secondary Satiety Visual analog scale on a scale of 0 to 100 mm. High score indicate better and low score indicate worse outcome. Change from baseline to 240 minutes
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