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
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 2, 2018
CompletedFirst Posted
Study publicly available on registry
October 5, 2018
CompletedOctober 10, 2018
October 1, 2018
9 months
October 2, 2018
October 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (31)
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
Study Arms (3)
High Protein
EXPERIMENTAL(40,6% protein)
Moderate Protein
EXPERIMENTAL(23.5% protein)
Low Protein
EXPERIMENTAL(12.4% protein)
Interventions
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.
Eligibility Criteria
You may qualify if:
- BMI 25-30 (obese)
- with stable body weight within the last 6 months (body weight change less than 4 kg)
- normal blood glucose level.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indonesia Universitylead
- SEAMEO Regional Centre for Food and Nutritioncollaborator
- Dr Cipto Mangunkusumo General Hospitalcollaborator
Study Sites (1)
Departement of Nutrition, Faculty of Medicine Universitas Indonesia
Jakarta, Jakarta Pusat, 10110, Indonesia
Related Publications (1)
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.
PMID: 30390699DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 2, 2018
First Posted
October 5, 2018
Study Start
October 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
October 10, 2018
Record last verified: 2018-10