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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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PYY, Ghrelin, Appetite, Gut Hormones, Obesity, Protein Consumption

Intervention / Treatment
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* Behavioral: diet with different composition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Protein<br>(40,6% protein) | Behavioral: diet with different composition<br>* 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.<br>|
| Experimental: Moderate Protein<br>(23.5% protein) | Behavioral: diet with different composition<br>* 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.<br>|
| Experimental: Low Protein<br>(12.4% protein) | Behavioral: diet with different composition<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PYY, ghrelin, ad libitum intake, high protein diet, moderately protein diet, low protein diet, breakfast, obesity