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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Ghrelin; Appetite; Gut Hormones; PYY; VAS of Satiety; VAS of Hunger; GLP - 1
• Intervention / Treatment: Behavioral: Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta Pusat
    • Jakarta, Jakarta Pusat, Indonesia, 10110
      • Departement of Nutrition, Faculty of Medicine Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obese; Women age 20-40, with BMI ≥ 25-35 kg/m2 Given a balanced breakfast (Protein 12,4%, carbohydrate 68,2%, fat 22,6%) with calories according to their energy requirement,which is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity. Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure every outcome. After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured.	Behavioral: Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women
Active Comparator: Non Obese; Women age 20-40, with BMI 18,5-23 kg/m2 Given a balanced breakfast (Protein 12,4%, carbohydrate 68,2%, fat 22,6%) with calories according to their energy requirement,which is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity. Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure every outcome. After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured.	Behavioral: Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ghrelin levels at 0 minute	analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm.	baseline
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
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
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
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
PYY levels at 0 minute	analyzed by Radioimmunoassay, directly taken after having the breakfast with balance composition in both of the study arm	baseline
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Dr Cipto Mangunkusumo General Hospital; SEAMEO Regional Centre for Food and Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: GuthormoneOB-NonOB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No