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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701503
• Other study ID #: GuthormoneOB-NonOB
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: July 2011

Study information

• Verified date: October 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appetite
• Ghrelin
• GLP - 1
• Gut Hormones
• Obesity
• PYY
• VAS of Hunger
• VAS of Satiety

Intervention

Behavioral:
• Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women

Locations

Country	Name	City	State
Indonesia	Departement of Nutrition, Faculty of Medicine Universitas Indonesia	Jakarta	Jakarta Pusat

Sponsors (3)

Lead Sponsor	Collaborator
Indonesia University	Dr Cipto Mangunkusumo General Hospital, SEAMEO Regional Centre for Food and Nutrition

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ghrelin levels at 0 minute	analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm.	baseline
Primary	Ghrelin levels at 15 minute	analyzed by ELISA, taken 15 minutes after having the breakfast with balance composition in both of the study arm.	15 minutes
Primary	Ghrelin levels at 60 minute	analyzed by ELISA, taken 60 minutes after having the breakfast with balance composition in both of the study arm.	60 minutes
Primary	Ghrelin levels at 120 minute	analyzed by ELISA, taken 120 minutes after having the breakfast with balance composition in both of the study arm	120 minutes
Primary	Ghrelin levels at 180 minute	analyzed by ELISA, taken 180 minutes after having the breakfast with balance composition in both of the study arm	180 minutes
Primary	PYY levels at 0 minute	analyzed by Radioimmunoassay, directly taken after having the breakfast with balance composition in both of the study arm	baseline
Primary	PYY levels at 15 minute	analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with balance composition in both of the study arm	15 minutes
Primary	PYY levels at 60 minute	analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with balance composition in both of the study arm	60 minutes
Primary	PYY levels at 120 minute	analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with balance composition in both of the study arm	120 minutes
Primary	PYY levels at 180 minute	analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with balance composition in both of the study arm	180 minutes
Primary	GLP-1 levels at 0 minute	analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm	baseline
Primary	GLP-1 levels at 15 minute	analyzed by ELISA, taken 15 minutes after having the breakfast with balance composition in both of the study arm	15 minutes
Primary	GLP-1 levels at 60 minute	analyzed by ELISA, taken 60 minutes after having the breakfast with balance composition in both of the study arm	60 minutes
Primary	GLP-1 levels at 120 minute	analyzed by ELISA, taken 120 minutes after having the breakfast with balance composition in both of the study arm	120 minutes
Primary	GLP-1 levels at 180 minute	analyzed by ELISA, taken 180 minutes after having the breakfast with balance composition in both of the study arm	180 minutes
Primary	Glucose levels at 0 minute	analyzed by standard random glucose level from venous blood, directly taken after having the breakfast with balanced composition in both of the study arm	baseline
Primary	Glucose levels at 15 minute	analyzed by standard random glucose level from venous blood, taken 15 minutes after having the breakfast with balanced composition in both of the study arm	15 minutes
Primary	Glucose levels at 60 minute	analyzed by standard random glucose level from venous blood, taken 60 minutes after having the breakfast with balanced composition in both of the study arm	60 minutes
Primary	Glucose levels at 120 minute	analyzed by standard random glucose level from venous blood, taken 120 minutes after having the breakfast with balanced composition in both of the study arm	120 minutes
Primary	Glucose levels at 180 minute	analyzed by standard random glucose level from venous blood, taken 180 minutes after having the breakfast with balanced composition in both of the study arm	180 minutes
Primary	Ad Libitum intake	Mean Ad Libitum intake (calories) in subjects four hours after breakfast with balance composition in both of the study arm	4 hours
Primary	VAS for hunger at 0 minutes	Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), directly taken after having the breakfast with balance composition in both of the study arm	baseline
Primary	VAS for hunger at 15 minutes	Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 15 minutes after having the breakfast with balance composition in both of the study arm	15 minutes
Primary	VAS for hunger at 60 minutes	Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 60 minutes after having the breakfast with balance composition in both of the study arm	60 minutes
Primary	VAS for hunger at 120 minutes	Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 120 minutes after having the breakfast with balance composition in both of the study arm	120 minutes
Primary	VAS for hunger at 180 minutes	Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 180 minutes after having the breakfast with balance composition in both of the study arm	180 minutes
Primary	VAS for satiety at 0 minutes	Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), directly taken after having the breakfast with balance composition in both of the study arm	baseline
Primary	VAS for satiety at 15 minutes	Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 15 minutes after having the breakfast with balance composition in both of the study arm	15 minutes
Primary	VAS for satiety at 60 minutes	Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 60 minutes after having the breakfast with balance composition in both of the study arm	60 minutes
Primary	VAS for satiety at 120 minutes	Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 120 minutes after having the breakfast with balance composition in both of the study arm	120 minutes
Primary	VAS for satiety at 180 minutes	Visual Analog Scale, a scale in the form of an empty straight line with no values but only several level point (ex: if the line is 10cm, then each cm represent 1 level). Extreme choices are both ends of the straight line. The minimum value is at the left end and the maximum value is at the right end. The subject must make a choice between the two ends of the line by giving an X mark (ex : if the subject feels less hunger, then the subject should mark X at the second point from far left), taken 180 minutes after having the breakfast with balance composition in both of the study arm	180 minutes