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Obesity, OverweightNCT05822167

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

A study testing High Protein Meal at Cold Temperature, High Protein Meal at Warm Temperarute and High Protein Meal at Hot Temperature in people with Obesity, Overweight, run by Khyber Medical University Peshawar at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 25 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight
What is being tested?
High Protein Meal at Cold Temperature, High Protein Meal at Warm Temperarute and High Protein Meal at Hot Temperature
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 sitePakistan
Study dates
20 Apr 2023to 28 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy individuals of age 25- 35 years
  • BMI ranged between 18.5 and 24.9

Who cannot join

  • Chronic diseases, diabetes, endocrine disorder,
  • Any bariatric surgery that interfered with gastrointestinal functions,
  • Smoking,
  • Dieting,
  • Pregnancy, lactation,
  • Taking medication or supplements.
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Khyber Medical University

    Peshawar, KPK, 25000

Other trials in Pakistan

About this study

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.

Read more

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.

Being tested
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
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
Medical subject headings
Obesity, Overweight, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Protein Meal at Cold TemperatureOther

    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 TemperaruteOther

    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 TemperatureOther

    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 TemperatureOther

    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 TemperatureOther

    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 TemperatureOther

    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 TemperatureOther

    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 TemperatureOther

    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 TemperatureOther

    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.

Study groups in NCT05822167
Study groupRoleWhat they receive
High Protein Meal with cold temperatureExperimentalNot described
Receives: Other: High Protein Meal at Cold Temperature
High Protein Meal with warm temperatureExperimentalNot described
Receives: Other: High Protein Meal at Warm Temperarute
High Protein Meal with Hot temperatureExperimentalNot described
Receives: Other: High Protein Meal at Hot Temperature
High Carbohydrate Meal with cold temperatureExperimentalNot described
Receives: Other: High Carbohydrate Meal at Cold Temperature
High Carbohydrate Meal with warm temperatureExperimentalNot described
Receives: Other: High Carbohydrate Meal at Warm Temperature
High Carbohydrate Meal with hot temperatureExperimentalNot described
Receives: Other: High Carbohydrate Meal at Hot Temperature
High Fat Meal with cold temperatureExperimentalNot described
Receives: Other: High Fat Meal at Cold Temperature
High Fat Meal with warm temperatureExperimentalNot described
Receives: Other: High Fat Meal at Warm Temperature
High Fat Meal with hot temperatureExperimentalNot described
Receives: Other: High Fat Meal at Hot Temperature

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hedonic 9-point

    Hedonic 9-point scale for acceptability of meal in terms of appearance, texture, smell, flavor and temperate.

    Measured: 30 minutes

  2. GLP-1

    Glucagon like peptide-1

    Measured: Change from baseline till 4 hours

  3. Chew Counting

    Chew Counting was done while the test meal is consumed by the participant by EMG and video recording same time.

    Measured: Up to 2 hours

  4. 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.

    Measured: Change from baseline till 1 hour

  5. CCK

    Cholecystokinin

    Measured: 0 minutes, 30 minutes and 180 minutes

  6. PYY

    Peptide tyrosine tyrosine

    Measured: Change from baseline to 180 minutes

  7. Ghrelin

    Human ghrelin

    Measured: Change from baseline to 120 minutes

  8. Glucose

    Pre-prandial baseline glucose and then after food intake

    Measured: Change from baseline to 120 minutes

  9. Insulin

    Pre-prandial baseline and after food intake

    Measured: Change from baseline to 180 minutes

  10. Serotonin

    Pre-prandial baseline and after food intake

    Measured: Change from baseline to 60 minutes

Secondary outcomes (2)
  1. 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.

    Measured: Up to 24 hours

  2. Satiety

    Visual analog scale on a scale of 0 to 100 mm. High score indicate better and low score indicate worse outcome.

    Measured: Change from baseline to 240 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start20 Apr 2023
  3. Primary completion28 Aug 2024
  4. Study completion28 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
3 interventional Studies 9 arms
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05822167
Sponsor's protocol ID
KMU/IBMS/IERB/2022/9303-7
Status last verified
Oct 2026
First submitted
6 Mar 2023
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 9846779
  • 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.

    PubMed 17124223
  • 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

  • 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.

    PubMed 25241326
  • 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.

    PubMed 23666746
  • Strader AD, Woods SC. Gastrointestinal hormones and food intake. Gastroenterology. 2005 Jan;128(1):175-91. doi: 10.1053/j.gastro.2004.10.043.

    PubMed 15633135
  • 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.

    PubMed 26429068
  • 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.

    PubMed 11956351
  • 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.

    PubMed 18468687
  • 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.

    PubMed 26188140
  • 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.

    PubMed 24847856
  • 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.

    PubMed 26838265
  • 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.

    PubMed 12088700

Questions about this trial

What is this clinical trial studying?

A study testing High Protein Meal at Cold Temperature, High Protein Meal at Warm Temperarute and High Protein Meal at Hot Temperature in people with Obesity, Overweight, run by Khyber Medical University Peshawar at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hedonic 9-point (time frame: 30 minutes). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05822167, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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