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

• ClinicalTrials.gov Identifier: NCT03701503
• Recruitment Status: Completed
• First Posted: October 10, 2018
• Last Update Posted: October 10, 2018
• Sponsor: Indonesia University
• Collaborators: SEAMEO Regional Centre for Food and Nutrition; Dr Cipto Mangunkusumo General Hospital
• Information provided by (Responsible Party): Fiastuti Witjaksono, Indonesia University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
PYY; Ghrelin; Appetite; Gut Hormones; Obesity; VAS of Satiety; VAS of Hunger; GLP - 1	Behavioral: Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 2010
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: July 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Ghrelin levels at 0 minute [ Time Frame: baseline ]
   analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm.
2. Ghrelin levels at 15 minute [ Time Frame: 15 minutes ]
   analyzed by ELISA, taken 15 minutes after having the breakfast with balance composition in both of the study arm.
3. Ghrelin levels at 60 minute [ Time Frame: 60 minutes ]
   analyzed by ELISA, taken 60 minutes after having the breakfast with balance composition in both of the study arm.
4. Ghrelin levels at 120 minute [ Time Frame: 120 minutes ]
   analyzed by ELISA, taken 120 minutes after having the breakfast with balance composition in both of the study arm
5. Ghrelin levels at 180 minute [ Time Frame: 180 minutes ]
   analyzed by ELISA, taken 180 minutes after having the breakfast with balance composition in both of the study arm
6. PYY levels at 0 minute [ Time Frame: baseline ]
   analyzed by Radioimmunoassay, directly taken after having the breakfast with balance composition in both of the study arm
7. PYY levels at 15 minute [ Time Frame: 15 minutes ]
   analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with balance composition in both of the study arm
8. PYY levels at 60 minute [ Time Frame: 60 minutes ]
   analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with balance composition in both of the study arm
9. PYY levels at 120 minute [ Time Frame: 120 minutes ]
   analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with balance composition in both of the study arm
10. PYY levels at 180 minute [ Time Frame: 180 minutes ]
    analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with balance composition in both of the study arm
11. GLP-1 levels at 0 minute [ Time Frame: baseline ]
    analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm
12. GLP-1 levels at 15 minute [ Time Frame: 15 minutes ]
    analyzed by ELISA, taken 15 minutes after having the breakfast with balance composition in both of the study arm
13. GLP-1 levels at 60 minute [ Time Frame: 60 minutes ]
    analyzed by ELISA, taken 60 minutes after having the breakfast with balance composition in both of the study arm
14. GLP-1 levels at 120 minute [ Time Frame: 120 minutes ]
    analyzed by ELISA, taken 120 minutes after having the breakfast with balance composition in both of the study arm
15. GLP-1 levels at 180 minute [ Time Frame: 180 minutes ]
    analyzed by ELISA, taken 180 minutes after having the breakfast with balance composition in both of the study arm
16. Glucose levels at 0 minute [ Time Frame: baseline ]
    analyzed by standard random glucose level from venous blood, directly taken after having the breakfast with balanced composition in both of the study arm
17. Glucose levels at 15 minute [ Time Frame: 15 minutes ]
    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
18. Glucose levels at 60 minute [ Time Frame: 60 minutes ]
    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
19. Glucose levels at 120 minute [ Time Frame: 120 minutes ]
    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
20. Glucose levels at 180 minute [ Time Frame: 180 minutes ]
    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
21. Ad Libitum intake [ Time Frame: 4 hours ]
    Mean Ad Libitum intake (calories) in subjects four hours after breakfast with balance composition in both of the study arm
22. VAS for hunger at 0 minutes [ Time Frame: baseline ]
    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
23. VAS for hunger at 15 minutes [ Time Frame: 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
24. VAS for hunger at 60 minutes [ Time Frame: 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
25. VAS for hunger at 120 minutes [ Time Frame: 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
26. VAS for hunger at 180 minutes [ Time Frame: 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
27. VAS for satiety at 0 minutes [ Time Frame: baseline ]
    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
28. VAS for satiety at 15 minutes [ Time Frame: 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
29. VAS for satiety at 60 minutes [ Time Frame: 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
30. VAS for satiety at 120 minutes [ Time Frame: 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
31. VAS for satiety at 180 minutes [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Indonesia

Departement of Nutrition, Faculty of Medicine Universitas Indonesia

Jakarta, Jakarta Pusat, Indonesia, 10110

Sponsors and Collaborators

Indonesia University

SEAMEO Regional Centre for Food and Nutrition

Dr Cipto Mangunkusumo General Hospital

More Information

• Responsible Party: Fiastuti Witjaksono, Principal Investigator, Indonesia University
• ClinicalTrials.gov Identifier: NCT03701503
• Other Study ID Numbers: GuthormoneOB-NonOB
• First Posted: October 10, 2018
• Last Update Posted: October 10, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs