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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Ghrelin; Appetite; Gut Hormones; PYY; Protein Consumption
• Intervention / Treatment: Behavioral: diet with different composition

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta Pusat
    • Jakarta, Jakarta Pusat, Indonesia, 10110
      • Departement of Nutrition, Faculty of Medicine Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ghrelin levels at 0 minute	analyzed by ELISA, directly taken after having the breakfast with different protein composition	baseline
Ghrelin levels at 15 minute	analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition	15 minutes
Ghrelin levels at 60 minute	analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition	60 minutes
Ghrelin levels at 120 minute	analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition	120 minutes
Ghrelin levels at 180 minute	analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition	180 minutes
PYY levels at 0 minute	analyzed by Radioimmunoassay, directly taken after having the breakfast with different protein composition	baseline
PYY levels at 15 minute	analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with different protein composition	15 minutes
PYY levels at 60 minute	analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with different protein composition	60 minutes
PYY levels at 120 minute	analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with different protein composition	120 minutes
PYY levels at 180 minute	analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with different protein composition	180 minutes
GLP-1 levels at 0 minute	analyzed by ELISA, directly taken after having the breakfast with different protein composition	baseline
GLP-1 levels at 15 minute	analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition	15 minutes
GLP-1 levels at 60 minute	analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition	60 minutes
GLP-1 levels at 120 minute	analyzed by ELISA, taken 120 minutes after having the breakfast with different protein composition	120 minutes
GLP-1 levels at 180 minute	analyzed by ELISA, taken 180 minutes after having the breakfast with different protein composition	180 minutes
Glucose levels at 0 minute	analyzed by standard random glucose level from venous blood, taken directly after having the breakfast with different protein composition	baseline
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	15 minutes
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	60 minutes
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	120 minutes
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	180 minutes
Ad Libitum intake	Mean Ad Libitum intake (calories) in subjects four hours after breakfast with different protein composition	4 hours
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	baseline
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	15 minutes
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	60 minutes
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	120 minutes
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	180 minutes
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	baseline
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	15 minutes
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	60 minutes
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	120 minutes
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	180 minutes

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Dr Cipto Mangunkusumo General Hospital; SEAMEO Regional Centre for Food and Nutrition

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2010
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (ACTUAL): October 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: obesity; breakfast; ghrelin; PYY; high protein diet; low protein diet; ad libitum intake; moderately protein diet
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: GuthormonesS3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No