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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697486
• Other study ID #: GuthormonesS3
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: July 2011

Study information

• Verified date: October 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appetite
• Ghrelin
• Gut Hormones
• Obesity
• Protein Consumption
• PYY

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Departement of Nutrition, Faculty of Medicine Universitas Indonesia	Jakarta	Jakarta Pusat

Sponsors (3)

Lead Sponsor	Collaborator
Indonesia University	Dr Cipto Mangunkusumo General Hospital, SEAMEO Regional Centre for Food and Nutrition

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ghrelin levels at 0 minute	analyzed by ELISA, directly taken after having the breakfast with different protein composition	baseline
Primary	Ghrelin levels at 15 minute	analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition	15 minutes
Primary	Ghrelin levels at 60 minute	analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition	60 minutes
Primary	Ghrelin levels at 120 minute	analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition	120 minutes
Primary	Ghrelin levels at 180 minute	analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition	180 minutes
Primary	PYY levels at 0 minute	analyzed by Radioimmunoassay, directly taken after having the breakfast with different protein composition	baseline
Primary	PYY levels at 15 minute	analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with different protein composition	15 minutes
Primary	PYY levels at 60 minute	analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with different protein composition	60 minutes
Primary	PYY levels at 120 minute	analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with different protein composition	120 minutes
Primary	PYY levels at 180 minute	analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with different protein composition	180 minutes
Primary	GLP-1 levels at 0 minute	analyzed by ELISA, directly taken after having the breakfast with different protein composition	baseline
Primary	GLP-1 levels at 15 minute	analyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition	15 minutes
Primary	GLP-1 levels at 60 minute	analyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition	60 minutes
Primary	GLP-1 levels at 120 minute	analyzed by ELISA, taken 120 minutes after having the breakfast with different protein composition	120 minutes
Primary	GLP-1 levels at 180 minute	analyzed by ELISA, taken 180 minutes after having the breakfast with different protein composition	180 minutes
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Ad Libitum intake	Mean Ad Libitum intake (calories) in subjects four hours after breakfast with different protein composition	4 hours
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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