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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

Not Applicable
Completed
Conditions
Obesity
Appetite
Protein Consumption
PYY
Gut Hormones
Ghrelin
Interventions
Behavioral: diet with different composition
Registration Number
NCT03697486
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
22
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
High Proteindiet with different composition(40,6% protein)
Moderate Proteindiet with different composition(23.5% protein)
Low Proteindiet with different composition(12.4% protein)
Primary Outcome Measures
NameTimeMethod
Ghrelin levels at 180 minute180 minutes

analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

PYY levels at 15 minute15 minutes

analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with different protein composition

GLP-1 levels at 0 minutebaseline

analyzed by ELISA, directly taken after having the breakfast with different protein composition

Glucose levels at 60 minute60 minutes

analyzed by standard random glucose level from venous blood, taken 60 minutes after having the breakfast with different protein composition

Ghrelin levels at 60 minute60 minutes

analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

Ghrelin levels at 120 minute120 minutes

analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

PYY levels at 0 minutebaseline

analyzed by Radioimmunoassay, directly taken after having the breakfast with different protein composition

PYY levels at 60 minute60 minutes

analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with different protein composition

GLP-1 levels at 120 minute120 minutes

analyzed by ELISA, taken 120 minutes after having the breakfast with different protein composition

Ad Libitum intake4 hours

Mean Ad Libitum intake (calories) in subjects four hours after breakfast with different protein composition

Ghrelin levels at 0 minutebaseline

analyzed by ELISA, directly taken after having the breakfast with different protein composition

Ghrelin levels at 15 minute15 minutes

analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition

PYY levels at 180 minute180 minutes

analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with different protein composition

Glucose levels at 0 minutebaseline

analyzed by standard random glucose level from venous blood, taken directly after having the breakfast with different protein composition

Glucose levels at 15 minute15 minutes

analyzed by standard random glucose level from venous blood, taken 15 minutes after having the breakfast with different protein composition

Glucose levels at 120 minute120 minutes

analyzed by standard random glucose level from venous blood, taken 120 minutes after having the breakfast with different protein composition

VAS for hunger at 15 minutes15 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 120 minutes120 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 minutes180 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

PYY levels at 120 minute120 minutes

analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with different protein composition

VAS for hunger at 60 minutes60 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 satiety at 0 minutebaseline

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

GLP-1 levels at 15 minute15 minutes

analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition

GLP-1 levels at 60 minute60 minutes

analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition

GLP-1 levels at 180 minute180 minutes

analyzed by ELISA, taken 180 minutes after having the breakfast with different protein composition

VAS for hunger at 0 minutesbaseline

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 satiety at 15 minute15 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 satiety at 60 minute60 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 satiety at 180 minute180 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 120 minute120 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

Glucose levels at 180 minute180 minutes

analyzed by standard random glucose level from venous blood, taken 180 minutes after having the breakfast with different protein composition

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Departement of Nutrition, Faculty of Medicine Universitas Indonesia

🇮🇩

Jakarta, Jakarta Pusat, Indonesia

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