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Completed

NCT Number: 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

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.

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Key information

Conditions

PYY Appetite Body Weight GLP - 1 Ghrelin Gut Hormones Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms VAS of Hunger VAS of Satiety

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Departement of Nutrition, Faculty of Medicine Universitas Indonesia

Jakarta, Jakarta Pusat, 10110, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Dr Cipto Mangunkusumo General Hospital
  • SEAMEO Regional Centre for Food and Nutrition

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 10, 2018
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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