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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

Primary Purpose

PYY, Ghrelin, Appetite

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
diet with different composition
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PYY focused on measuring PYY, ghrelin, ad libitum intake, high protein diet, moderately protein diet, low protein diet, breakfast, obesity

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Departement of Nutrition, Faculty of Medicine Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

High Protein

Moderate Protein

Low Protein

Arm Description

(40,6% protein)

(23.5% protein)

(12.4% protein)

Outcomes

Primary Outcome Measures

Ghrelin levels at 0 minute
analyzed by ELISA, directly taken after having the breakfast with different protein composition
Ghrelin levels at 15 minute
analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition
Ghrelin levels at 60 minute
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
Ghrelin levels at 120 minute
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
Ghrelin levels at 180 minute
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
PYY levels at 0 minute
analyzed by Radioimmunoassay, directly taken after having the breakfast with different protein composition
PYY levels at 15 minute
analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with different protein composition
PYY levels at 60 minute
analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with different protein composition
PYY levels at 120 minute
analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with different protein composition
PYY levels at 180 minute
analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with different protein composition
GLP-1 levels at 0 minute
analyzed by ELISA, directly taken after having the breakfast with different protein composition
GLP-1 levels at 15 minute
analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition
GLP-1 levels at 60 minute
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
GLP-1 levels at 120 minute
analyzed by ELISA, taken 120 minutes after having the breakfast with different protein composition
GLP-1 levels at 180 minute
analyzed by ELISA, taken 180 minutes after having the breakfast with different protein composition
Glucose levels at 0 minute
analyzed by standard random glucose level from venous blood, taken directly after having the breakfast with different protein composition
Glucose levels at 15 minute
analyzed by standard random glucose level from venous blood, taken 15 minutes after having the breakfast with different protein composition
Glucose levels at 60 minute
analyzed by standard random glucose level from venous blood, taken 60 minutes after having the breakfast with different protein composition
Glucose levels at 120 minute
analyzed by standard random glucose level from venous blood, taken 120 minutes after having the breakfast with different protein composition
Glucose levels at 180 minute
analyzed by standard random glucose level from venous blood, taken 180 minutes after having the breakfast with different protein composition
Ad Libitum intake
Mean Ad Libitum intake (calories) in subjects four hours after breakfast with different protein composition
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 different protein composition
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 different protein composition
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 different protein composition
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 different protein composition
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 different protein composition
VAS for satiety at 0 minute
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
VAS for satiety at 15 minute
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
VAS for satiety at 60 minute
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
VAS for satiety at 120 minute
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
VAS for satiety at 180 minute
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

Secondary Outcome Measures

Full Information

First Posted
October 2, 2018
Last Updated
October 8, 2018
Sponsor
Indonesia University
Collaborators
SEAMEO Regional Centre for Food and Nutrition, Dr Cipto Mangunkusumo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03697486
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
SEAMEO Regional Centre for Food and Nutrition, Dr Cipto Mangunkusumo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PYY, Ghrelin, Appetite, Gut Hormones, Obesity, Protein Consumption
Keywords
PYY, ghrelin, ad libitum intake, high protein diet, moderately protein diet, low protein diet, breakfast, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Protein
Arm Type
Experimental
Arm Description
(40,6% protein)
Arm Title
Moderate Protein
Arm Type
Experimental
Arm Description
(23.5% protein)
Arm Title
Low Protein
Arm Type
Experimental
Arm Description
(12.4% protein)
Intervention Type
Behavioral
Intervention Name(s)
diet with different composition
Intervention Description
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 Measure Information:
Title
Ghrelin levels at 0 minute
Description
analyzed by ELISA, directly taken after having the breakfast with different protein composition
Time Frame
baseline
Title
Ghrelin levels at 15 minute
Description
analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition
Time Frame
15 minutes
Title
Ghrelin levels at 60 minute
Description
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
Time Frame
60 minutes
Title
Ghrelin levels at 120 minute
Description
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
Time Frame
120 minutes
Title
Ghrelin levels at 180 minute
Description
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
Time Frame
180 minutes
Title
PYY levels at 0 minute
Description
analyzed by Radioimmunoassay, directly taken after having the breakfast with different protein composition
Time Frame
baseline
Title
PYY levels at 15 minute
Description
analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with different protein composition
Time Frame
15 minutes
Title
PYY levels at 60 minute
Description
analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with different protein composition
Time Frame
60 minutes
Title
PYY levels at 120 minute
Description
analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with different protein composition
Time Frame
120 minutes
Title
PYY levels at 180 minute
Description
analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with different protein composition
Time Frame
180 minutes
Title
GLP-1 levels at 0 minute
Description
analyzed by ELISA, directly taken after having the breakfast with different protein composition
Time Frame
baseline
Title
GLP-1 levels at 15 minute
Description
analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition
Time Frame
15 minutes
Title
GLP-1 levels at 60 minute
Description
analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
Time Frame
60 minutes
Title
GLP-1 levels at 120 minute
Description
analyzed by ELISA, taken 120 minutes after having the breakfast with different protein composition
Time Frame
120 minutes
Title
GLP-1 levels at 180 minute
Description
analyzed by ELISA, taken 180 minutes after having the breakfast with different protein composition
Time Frame
180 minutes
Title
Glucose levels at 0 minute
Description
analyzed by standard random glucose level from venous blood, taken directly after having the breakfast with different protein composition
Time Frame
baseline
Title
Glucose levels at 15 minute
Description
analyzed by standard random glucose level from venous blood, taken 15 minutes after having the breakfast with different protein composition
Time Frame
15 minutes
Title
Glucose levels at 60 minute
Description
analyzed by standard random glucose level from venous blood, taken 60 minutes after having the breakfast with different protein composition
Time Frame
60 minutes
Title
Glucose levels at 120 minute
Description
analyzed by standard random glucose level from venous blood, taken 120 minutes after having the breakfast with different protein composition
Time Frame
120 minutes
Title
Glucose levels at 180 minute
Description
analyzed by standard random glucose level from venous blood, taken 180 minutes after having the breakfast with different protein composition
Time Frame
180 minutes
Title
Ad Libitum intake
Description
Mean Ad Libitum intake (calories) in subjects four hours after breakfast with different protein composition
Time Frame
4 hours
Title
VAS for hunger at 0 minutes
Description
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
Time Frame
baseline
Title
VAS for hunger at 15 minutes
Description
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
Time Frame
15 minutes
Title
VAS for hunger at 60 minutes
Description
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
Time Frame
60 minutes
Title
VAS for hunger at 120 minutes
Description
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
Time Frame
120 minutes
Title
VAS for hunger at 180 minutes
Description
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
Time Frame
180 minutes
Title
VAS for satiety at 0 minute
Description
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
Time Frame
baseline
Title
VAS for satiety at 15 minute
Description
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
Time Frame
15 minutes
Title
VAS for satiety at 60 minute
Description
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
Time Frame
60 minutes
Title
VAS for satiety at 120 minute
Description
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
Time Frame
120 minutes
Title
VAS for satiety at 180 minute
Description
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
Time Frame
180 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Departement of Nutrition, Faculty of Medicine Universitas Indonesia
City
Jakarta
State/Province
Jakarta Pusat
ZIP/Postal Code
10110
Country
Indonesia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30390699
Citation
Witjaksono F, Lukito W, Wijaya A, Annisa NG, Jutamulia J, Nurwidya F, Simadibrata M. The effect of breakfast with different macronutrient composition on PYY, ghrelin, and ad libitum intake 4 h after breakfast in Indonesian obese women. BMC Res Notes. 2018 Nov 3;11(1):787. doi: 10.1186/s13104-018-3895-3.
Results Reference
derived

Learn more about this trial

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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