Clinical trial NCT03701503: The Comparison of PYY, Ghrelin, GLP1, Glucose Level, Level of Satiety, and Ad Libitum Intake in Obese and Non-Obese Patients After Breakfast With Balanced Macronutrient Composition
Official title: The Comparison of PYY, Ghrelin, GLP1, Glucose Level, VAS Level of Satiety, VAS Level of Hunger and Ad Libitum Intake in Obese and Non-Obese Patients After Breakfast With Balanced Macronutrient Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PYY
Ghrelin
Appetite
Gut Hormones
Obesity
VAS of Satiety
VAS of Hunger
GLP - 1
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: SEAMEO Regional Centre for Food and Nutrition
name: Dr Cipto Mangunkusumo General Hospital
First posted: 2018-10-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity can occur due to an imbalance of energy. This energy balance is greatly influenced by hunger and satiety. Obese person cannot resist hunger, while non obese can control hunger. Gut hormones, such as PYY and ghrelin, are associated with appetite and satiety control. This study's objective is to compare the effect of breakfast with balance composition on gut hormones, glucose and ad libitum intake four hours after breakfast between obese and non obese..

The research methodology was used a clinical trial with 18 obese women and 22 non obese women participants. Subjects were given a balance breakfast (protein 12,4%, carbohydrate 68,2%, fat 22,6%). Gut hormones (PYY, Ghrelin, GLP -1) level , Glucose level and satiety level were measured at 0, 15, 60, 120, and 180 minutes after breakfast. Ad libitum meal was given four hours after breakfast and measured after.


Eligibility criteria: Inclusion Criteria:

* BMI 25 - 30 (for obese am)
* BMI 18,5 - 23 (for NON- obese am)
* with stable body weight within the last 6 months (body weight change less than 4 kg)
* normal blood glucose level.

Exclusion Criteria:

* Patients who never had breakfast
* patients in weight loss program
* patients consuming lipid-absorption inhibitor or appetite-suppressing drugs
* patients that have had gastrointestinal tract resection.

Primary outcomes:
measure: Ghrelin levels at 0 minute
timeFrame: baseline
measure: Ghrelin levels at 15 minute
timeFrame: 15 minutes
measure: Ghrelin levels at 60 minute
timeFrame: 60 minutes
measure: Ghrelin levels at 120 minute
timeFrame: 120 minutes
measure: Ghrelin levels at 180 minute
timeFrame: 180 minutes
measure: PYY levels at 0 minute
timeFrame: baseline
measure: PYY levels at 15 minute
timeFrame: 15 minutes
measure: PYY levels at 60 minute
timeFrame: 60 minutes
measure: PYY levels at 120 minute
timeFrame: 120 minutes
measure: PYY levels at 180 minute
timeFrame: 180 minutes
measure: GLP-1 levels at 0 minute
timeFrame: baseline
measure: GLP-1 levels at 15 minute
timeFrame: 15 minutes
measure: GLP-1 levels at 60 minute
timeFrame: 60 minutes
measure: GLP-1 levels at 120 minute
timeFrame: 120 minutes
measure: GLP-1 levels at 180 minute
timeFrame: 180 minutes
measure: Glucose levels at 0 minute
timeFrame: baseline
measure: Glucose levels at 15 minute
timeFrame: 15 minutes
measure: Glucose levels at 60 minute
timeFrame: 60 minutes
measure: Glucose levels at 120 minute
timeFrame: 120 minutes
measure: Glucose levels at 180 minute
timeFrame: 180 minutes
measure: Ad Libitum intake
timeFrame: 4 hours
measure: VAS for hunger at 0 minutes
timeFrame: baseline
measure: VAS for hunger at 15 minutes
timeFrame: 15 minutes
measure: VAS for hunger at 60 minutes
timeFrame: 60 minutes
measure: VAS for hunger at 120 minutes
timeFrame: 120 minutes
measure: VAS for hunger at 180 minutes
timeFrame: 180 minutes
measure: VAS for satiety at 0 minutes
timeFrame: baseline
measure: VAS for satiety at 15 minutes
timeFrame: 15 minutes
measure: VAS for satiety at 60 minutes
timeFrame: 60 minutes
measure: VAS for satiety at 120 minutes
timeFrame: 120 minutes
measure: VAS for satiety at 180 minutes
timeFrame: 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Departement of Nutrition, Faculty of Medicine Universitas Indonesia
state: Jakarta Pusat
Study officials:
References: