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Trial record 3 of 406 for:    PYY

The Effect of Breakfast With Different Macronutrient Composition on PYY, Ghrelin, GLP-1,Glucose Level, VAS for Hunger, VAS for Satiety and Ad Libitum Intake 4 Hours After Breakfast in Obese Women

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ClinicalTrials.gov Identifier: NCT03697486
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : October 10, 2018
Sponsor:
Collaborators:
SEAMEO Regional Centre for Food and Nutrition
Dr Cipto Mangunkusumo General Hospital
Information provided by (Responsible Party):
Fiastuti Witjaksono, Indonesia University

Brief Summary:

Gut hormones, such as PYY and ghrelin, are associated with appetite control and obesity. Protein is thought to be the most satieting nutrient and could affect production of several gut hormones. This study's objective is to find the effect of breakfast with different protein composition on PYY, ghrelin, and ad libitum intake four hours after breakfast.

The research methodology was used a clinical trial with 22 obese women participants. Subjects were given three types of breakfast: low protein consumption (12.4% protein), medium protein (23.5% protein), and high protein (40,6% protein). PYY and ghrelin 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 Protein Consumption Behavioral: diet with different composition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Breakfast With Different Macronutrient Composition on PYY, Ghrelin, GLP-1, Glucose Level, VAS for Hunger, VAS for Satiety and Ad Libitum Intake 4 Hours After Breakfast in Obese Women
Actual Study Start Date : October 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: High Protein
(40,6% protein)
Behavioral: diet with different composition

Participants should not eat within the last 10 hours. Participants could drink mineral water up to 2 hours before intervention. Breakfast given is a milk-based formula which has to be finished within 15 minutes, and subjects could only consume 600 mL of mineral water within the next 4 hours after intervention. Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure ghrelin and PYY level. Breakfast given is adjusted to participants' energy requirement. Energy requirement is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity. Different composition of protein, carbohydrate and fat were given to each arm depends on their group.

After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured.


Experimental: Moderate Protein
(23.5% protein)
Behavioral: diet with different composition

Participants should not eat within the last 10 hours. Participants could drink mineral water up to 2 hours before intervention. Breakfast given is a milk-based formula which has to be finished within 15 minutes, and subjects could only consume 600 mL of mineral water within the next 4 hours after intervention. Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure ghrelin and PYY level. Breakfast given is adjusted to participants' energy requirement. Energy requirement is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity. Different composition of protein, carbohydrate and fat were given to each arm depends on their group.

After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured.


Experimental: Low Protein
(12.4% protein)
Behavioral: diet with different composition

Participants should not eat within the last 10 hours. Participants could drink mineral water up to 2 hours before intervention. Breakfast given is a milk-based formula which has to be finished within 15 minutes, and subjects could only consume 600 mL of mineral water within the next 4 hours after intervention. Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure ghrelin and PYY level. Breakfast given is adjusted to participants' energy requirement. Energy requirement is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity. Different composition of protein, carbohydrate and fat were given to each arm depends on their group.

After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured.





Primary Outcome Measures :
  1. Ghrelin levels at 0 minute [ Time Frame: baseline ]
    analyzed by ELISA, directly taken after having the breakfast with different protein composition

  2. Ghrelin levels at 15 minute [ Time Frame: 15 minutes ]
    analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition

  3. Ghrelin levels at 60 minute [ Time Frame: 60 minutes ]
    analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

  4. Ghrelin levels at 120 minute [ Time Frame: 120 minutes ]
    analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

  5. Ghrelin levels at 180 minute [ Time Frame: 180 minutes ]
    analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

  6. PYY levels at 0 minute [ Time Frame: baseline ]
    analyzed by Radioimmunoassay, directly taken after having the breakfast with different protein composition

  7. PYY levels at 15 minute [ Time Frame: 15 minutes ]
    analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with different protein composition

  8. PYY levels at 60 minute [ Time Frame: 60 minutes ]
    analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with different protein composition

  9. PYY levels at 120 minute [ Time Frame: 120 minutes ]
    analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with different protein composition

  10. PYY levels at 180 minute [ Time Frame: 180 minutes ]
    analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with different protein composition

  11. GLP-1 levels at 0 minute [ Time Frame: baseline ]
    analyzed by ELISA, directly taken after having the breakfast with different protein composition

  12. GLP-1 levels at 15 minute [ Time Frame: 15 minutes ]
    analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition

  13. GLP-1 levels at 60 minute [ Time Frame: 60 minutes ]
    analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

  14. GLP-1 levels at 120 minute [ Time Frame: 120 minutes ]
    analyzed by ELISA, taken 120 minutes after having the breakfast with different protein composition

  15. GLP-1 levels at 180 minute [ Time Frame: 180 minutes ]
    analyzed by ELISA, taken 180 minutes after having the breakfast with different protein composition

  16. Glucose levels at 0 minute [ Time Frame: baseline ]
    analyzed by standard random glucose level from venous blood, taken directly after having the breakfast with different protein composition

  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 different protein composition

  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 different protein composition

  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 different protein composition

  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 different protein composition

  21. Ad Libitum intake [ Time Frame: 4 hours ]
    Mean Ad Libitum intake (calories) in subjects four hours after breakfast with different protein composition

  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 different protein composition

  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 different protein composition

  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 different protein composition

  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 different protein composition

  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 different protein composition

  27. VAS for satiety at 0 minute [ 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), taken directly after having the breakfast with different protein composition

  28. VAS for satiety at 15 minute [ 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 different protein composition

  29. VAS for satiety at 60 minute [ 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 different protein composition

  30. VAS for satiety at 120 minute [ 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 different protein composition

  31. VAS for satiety at 180 minute [ 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 different protein composition



Information from the National Library of Medicine

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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 (obese)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697486


Locations
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fiastuti Witjaksono, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03697486     History of Changes
Other Study ID Numbers: GuthormonesS3
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fiastuti Witjaksono, Indonesia University:
PYY
ghrelin
ad libitum intake
high protein diet
moderately protein diet
low protein diet
breakfast
obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Nutrients
Growth Substances
Physiological Effects of Drugs