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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03697486
Enrollment
22
Registered
2018-10-05
Start date
2010-10-31
Completion date
2011-07-31
Last updated
2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

PYY, ghrelin, ad libitum intake, high protein diet, moderately protein diet, low protein diet, breakfast, obesity

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.

Interventions

BEHAVIORALdiet 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.

Sponsors

SEAMEO Regional Centre for Food and Nutrition
CollaboratorOTHER
Dr Cipto Mangunkusumo General Hospital
CollaboratorOTHER
Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
VAS for satiety at 120 minute120 minutesVisual 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 minute180 minutesVisual 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
Ghrelin levels at 0 minutebaselineanalyzed by ELISA, directly taken after having the breakfast with different protein composition
Ghrelin levels at 15 minute15 minutesanalyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition
Ghrelin levels at 60 minute60 minutesanalyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
Ghrelin levels at 120 minute120 minutesanalyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
Ghrelin levels at 180 minute180 minutesanalyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
PYY levels at 0 minutebaselineanalyzed by Radioimmunoassay, directly taken after having the breakfast with different protein composition
PYY levels at 15 minute15 minutesanalyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with different protein composition
PYY levels at 60 minute60 minutesanalyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with different protein composition
PYY levels at 120 minute120 minutesanalyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with different protein composition
PYY levels at 180 minute180 minutesanalyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with different protein composition
GLP-1 levels at 0 minutebaselineanalyzed by ELISA, directly taken after having the breakfast with different protein composition
GLP-1 levels at 15 minute15 minutesanalyzed by ELISA, taken 15 minutes after having the breakfast with different protein composition
GLP-1 levels at 60 minute60 minutesanalyzed by ELISA, taken 60 minutes after having the breakfast with different protein composition
GLP-1 levels at 120 minute120 minutesanalyzed by ELISA, taken 120 minutes after having the breakfast with different protein composition
GLP-1 levels at 180 minute180 minutesanalyzed by ELISA, taken 180 minutes after having the breakfast with different protein composition
Glucose levels at 0 minutebaselineanalyzed by standard random glucose level from venous blood, taken directly after having the breakfast with different protein composition
Glucose levels at 15 minute15 minutesanalyzed by standard random glucose level from venous blood, taken 15 minutes after having the breakfast with different protein composition
Glucose levels at 60 minute60 minutesanalyzed by standard random glucose level from venous blood, taken 60 minutes after having the breakfast with different protein composition
Glucose levels at 120 minute120 minutesanalyzed by standard random glucose level from venous blood, taken 120 minutes after having the breakfast with different protein composition
Glucose levels at 180 minute180 minutesanalyzed by standard random glucose level from venous blood, taken 180 minutes after having the breakfast with different protein composition
Ad Libitum intake4 hoursMean Ad Libitum intake (calories) in subjects four hours after breakfast with different protein composition
VAS for hunger at 0 minutesbaselineVisual 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 minutes15 minutesVisual 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 minutes60 minutesVisual 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 minutes120 minutesVisual 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 minutesVisual 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 minutebaselineVisual 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 minute15 minutesVisual 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 minutesVisual 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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026