NCT05822167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2023

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

March 6, 2023

Last Update Submit

July 23, 2024

Conditions

Keywords

SatietyFood IntakeFood TemperatureFood CompositionGut HormonesSatiety-related HormonesChewing timeAppetiteSatiety ScoreEEGBrain WavesEMGCCKGLP-1InsulinPeptide YYGhrelinhigh Protein mealhigh Fat mealHigh Carbohydrate mealChewing countAlpha wave

Outcome Measures

Primary Outcomes (10)

  • Hedonic 9-point

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

    30 minutes

  • GLP-1

    Glucagon like peptide-1

    Change from baseline till 4 hours

  • 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

  • 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

  • CCK

    Cholecystokinin

    0 minutes, 30 minutes and 180 minutes

  • PYY

    Peptide tyrosine tyrosine

    Change from baseline to 180 minutes

  • Ghrelin

    Human ghrelin

    Change from baseline to 120 minutes

  • Glucose

    Pre-prandial baseline glucose and then after food intake

    Change from baseline to 120 minutes

  • Insulin

    Pre-prandial baseline and after food intake

    Change from baseline to 180 minutes

  • Serotonin

    Pre-prandial baseline and after food intake

    Change from baseline to 60 minutes

Secondary Outcomes (2)

  • Remainder food intake

    Up to 24 hours

  • Satiety

    Change from baseline to 240 minutes

Study Arms (9)

High Protein Meal with cold temperature

EXPERIMENTAL
Other: High Protein Meal at Cold Temperature

High Protein Meal with warm temperature

EXPERIMENTAL
Other: High Protein Meal at Warm Temperarute

High Protein Meal with Hot temperature

EXPERIMENTAL
Other: High Protein Meal at Hot Temperature

High Carbohydrate Meal with cold temperature

EXPERIMENTAL
Other: High Carbohydrate Meal at Cold Temperature

High Carbohydrate Meal with warm temperature

EXPERIMENTAL
Other: High Carbohydrate Meal at Warm Temperature

High Carbohydrate Meal with hot temperature

EXPERIMENTAL
Other: High Carbohydrate Meal at Hot Temperature

High Fat Meal with cold temperature

EXPERIMENTAL
Other: High Fat Meal at Cold Temperature

High Fat Meal with warm temperature

EXPERIMENTAL
Other: High Fat Meal at Warm Temperature

High Fat Meal with hot temperature

EXPERIMENTAL
Other: High Fat Meal at Hot Temperature

Interventions

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 with cold temperature

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 with warm 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 Protein Meal with Hot 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 with cold 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 with 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 hot temperature i.e., 60 degree C and above.

High Carbohydrate Meal with hot 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 with cold 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 with warm 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.

High Fat Meal with hot temperature

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Medical University

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (14)

  • 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.

    PMID: 9846779BACKGROUND
  • 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.

    PMID: 17124223BACKGROUND
  • 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

    BACKGROUND
  • 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).

    BACKGROUND
  • 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.

    PMID: 25241326BACKGROUND
  • 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.

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

    PMID: 15633135BACKGROUND
  • 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.

    PMID: 26429068BACKGROUND
  • 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.

    PMID: 11956351BACKGROUND
  • 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.

    PMID: 18468687BACKGROUND
  • 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.

    PMID: 26188140BACKGROUND
  • 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.

    PMID: 24847856BACKGROUND
  • 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.

    PMID: 26838265BACKGROUND
  • 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.

    PMID: 12088700BACKGROUND

MeSH Terms

Conditions

ObesityOverweightInsulin Resistance

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 3 interventional Studies 9 arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 6, 2023

First Posted

April 20, 2023

Study Start

April 20, 2023

Primary Completion

August 28, 2023

Study Completion

August 28, 2023

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations