PYYNCT03701503
The Comparison of PYY, Ghrelin, GLP1, Glucose Level, Level of Satiety, and Ad Libitum Intake in Obese and Non-Obese Patients After Breakfast With Balanced Macronutrient Composition
A study testing Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women in people with PYY and Ghrelin, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Obesity can occur due to an imbalance of energy. This energy balance is greatly influenced by hunger and satiety. Obese person cannot resist hunger, while non obese can control hunger. Gut hormones, such as PYY and ghrelin, are associated with appetite and satiety control. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- What is being tested?
- Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25 - 30 (for obese am)
- BMI 18,5 - 23 (for NON- obese am)
- with stable body weight within the last 6 months (body weight change less than 4 kg)
- normal blood glucose level.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Departement of Nutrition, Faculty of Medicine Universitas Indonesia
Jakarta, Jakarta Pusat, 10110
About this study
Official title: The Comparison of PYY, Ghrelin, GLP1, Glucose Level, VAS Level of Satiety, VAS Level of Hunger and Ad Libitum Intake in Obese and Non-Obese Patients After Breakfast With Balanced Macronutrient Composition
Obesity can occur due to an imbalance of energy. This energy balance is greatly influenced by hunger and satiety. Obese person cannot resist hunger, while non obese can control hunger. Gut hormones, such as PYY and ghrelin, are associated with appetite and satiety control. This study's objective is to compare the effect of breakfast with balance composition on gut hormones, glucose and ad libitum intake four hours after breakfast between obese and non obese..
The research methodology was used a clinical trial with 18 obese women and 22 non obese women participants. Subjects were given a balance breakfast (protein 12,4%, carbohydrate 68,2%, fat 22,6%). Gut hormones (PYY, Ghrelin, GLP -1) level , Glucose level and satiety 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.
- Conditions
- PYY, Ghrelin, Appetite, Gut Hormones, Obesity, VAS of Satiety
- Being tested
- Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese womenBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Obese | Experimental | Women age 20-40, with BMI ≥ 25-35 kg/m2 Given a balanced breakfast (Protein 12,4%, carbohydrate 68,2%, fat 22,6%) with calories according to their energy requirement,which is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity.
Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure every outcome. After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured. Receives: Behavioral: Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women |
| Non Obese | Active comparator | Women age 20-40, with BMI 18,5-23 kg/m2 Given a balanced breakfast (Protein 12,4%, carbohydrate 68,2%, fat 22,6%) with calories according to their energy requirement,which is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity.
Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure every outcome. After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured. Receives: Behavioral: Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ghrelin levels at 0 minute
analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm.
Measured: baseline
Ghrelin levels at 15 minute
analyzed by ELISA, taken 15 minutes after having the breakfast with balance composition in both of the study arm.
Measured: 15 minutes
Ghrelin levels at 60 minute
analyzed by ELISA, taken 60 minutes after having the breakfast with balance composition in both of the study arm.
Measured: 60 minutes
Ghrelin levels at 120 minute
analyzed by ELISA, taken 120 minutes after having the breakfast with balance composition in both of the study arm
Measured: 120 minutes
Ghrelin levels at 180 minute
analyzed by ELISA, taken 180 minutes after having the breakfast with balance composition in both of the study arm
Measured: 180 minutes
PYY levels at 0 minute
analyzed by Radioimmunoassay, directly taken after having the breakfast with balance composition in both of the study arm
Measured: baseline
PYY levels at 15 minute
analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with balance composition in both of the study arm
Measured: 15 minutes
PYY levels at 60 minute
analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with balance composition in both of the study arm
Measured: 60 minutes
PYY levels at 120 minute
analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with balance composition in both of the study arm
Measured: 120 minutes
PYY levels at 180 minute
analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with balance composition in both of the study arm
Measured: 180 minutes
GLP-1 levels at 0 minute
analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm
Measured: baseline
GLP-1 levels at 15 minute
analyzed by ELISA, taken 15 minutes after having the breakfast with balance composition in both of the study arm
Measured: 15 minutes
GLP-1 levels at 60 minute
analyzed by ELISA, taken 60 minutes after having the breakfast with balance composition in both of the study arm
Measured: 60 minutes
GLP-1 levels at 120 minute
analyzed by ELISA, taken 120 minutes after having the breakfast with balance composition in both of the study arm
Measured: 120 minutes
GLP-1 levels at 180 minute
analyzed by ELISA, taken 180 minutes after having the breakfast with balance composition in both of the study arm
Measured: 180 minutes
Glucose levels at 0 minute
analyzed by standard random glucose level from venous blood, directly taken after having the breakfast with balanced composition in both of the study arm
Measured: baseline
Glucose levels at 15 minute
analyzed by standard random glucose level from venous blood, taken 15 minutes after having the breakfast with balanced composition in both of the study arm
Measured: 15 minutes
Glucose levels at 60 minute
analyzed by standard random glucose level from venous blood, taken 60 minutes after having the breakfast with balanced composition in both of the study arm
Measured: 60 minutes
Glucose levels at 120 minute
analyzed by standard random glucose level from venous blood, taken 120 minutes after having the breakfast with balanced composition in both of the study arm
Measured: 120 minutes
Glucose levels at 180 minute
analyzed by standard random glucose level from venous blood, taken 180 minutes after having the breakfast with balanced composition in both of the study arm
Measured: 180 minutes
Ad Libitum intake
Mean Ad Libitum intake (calories) in subjects four hours after breakfast with balance composition in both of the study arm
Measured: 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 balance composition in both of the study arm
Measured: 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 balance composition in both of the study arm
Measured: 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 balance composition in both of the study arm
Measured: 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 balance composition in both of the study arm
Measured: 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 balance composition in both of the study arm
Measured: 180 minutes
VAS for satiety 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 balance composition in both of the study arm
Measured: baseline
VAS for satiety 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 balance composition in both of the study arm
Measured: 15 minutes
VAS for satiety 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 balance composition in both of the study arm
Measured: 60 minutes
VAS for satiety 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 balance composition in both of the study arm
Measured: 120 minutes
VAS for satiety 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 balance composition in both of the study arm
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study startOct 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PYYStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- SEAMEO Regional Centre for Food and Nutrition, Dr Cipto Mangunkusumo General Hospital
- Responsible party
- Principal investigator, Fiastuti Witjaksono, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701503
- Sponsor's protocol ID
- GuthormoneOB-NonOB
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of PYY, Ghrelin, GLP1, Glucose Level, VAS Level of Satiety, VAS Level of Hunger and Ad Libitum Intake in Obese and Non-Obese Patients After Breakfast With Balanced Macronutrient Composition
- ClinicalTrials.gov ID
- NCT03701503
- Acronym / sponsor ID
- GuthormoneOB-NonOB
- Conditions
- PYY, Ghrelin, Appetite, Gut Hormones, Obesity, VAS of Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- SEAMEO Regional Centre for Food and Nutrition, Dr Cipto Mangunkusumo General Hospital
- Study start
- Oct 2010 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity can occur due to an imbalance of energy. This energy balance is greatly influenced by hunger and satiety. Obese person cannot resist hunger, while non obese can control hunger. Gut hormones, such as PYY and ghrelin, are associated with appetite and satiety control. This study's objective is to compare the effect of breakfast with balance composition on gut hormones, glucose and ad libitum intake four hours after breakfast between obese and non obese..
The research methodology was used a clinical trial with 18 obese women and 22 non obese women participants. Subjects were given a balance breakfast (protein 12,4%, carbohydrate 68,2%, fat 22,6%). Gut hormones (PYY, Ghrelin, GLP -1) level , Glucose level and satiety 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | Experimental | Behavioral: Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese womenWomen age 20-40, with BMI ≥ 25-35 kg/m2 Given a balanced breakfast (Protein 12,4%, carbohydrate 68,2%, fat 22,6%) with calories according to their energy requirement,which is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity. Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure every outcome. After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured. |
| Non Obese | Active comparator | Behavioral: Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese womenWomen age 20-40, with BMI 18,5-23 kg/m2 Given a balanced breakfast (Protein 12,4%, carbohydrate 68,2%, fat 22,6%) with calories according to their energy requirement,which is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity. Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure every outcome. After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 25 - 30 (for obese am)
- BMI 18,5 - 23 (for NON- obese am)
- with stable body weight within the last 6 months (body weight change less than 4 kg)
- normal blood glucose level.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women | Behavioural | Non Obese, Obese |
Primary outcome
Ghrelin levels at 0 minute
Time frame: baseline
analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm.
Ghrelin levels at 15 minute
Time frame: 15 minutes
analyzed by ELISA, taken 15 minutes after having the breakfast with balance composition in both of the study arm.
Ghrelin levels at 60 minute
Time frame: 60 minutes
analyzed by ELISA, taken 60 minutes after having the breakfast with balance composition in both of the study arm.
Ghrelin levels at 120 minute
Time frame: 120 minutes
analyzed by ELISA, taken 120 minutes after having the breakfast with balance composition in both of the study arm
Ghrelin levels at 180 minute
Time frame: 180 minutes
analyzed by ELISA, taken 180 minutes after having the breakfast with balance composition in both of the study arm
PYY levels at 0 minute
Time frame: baseline
analyzed by Radioimmunoassay, directly taken after having the breakfast with balance composition in both of the study arm
PYY levels at 15 minute
Time frame: 15 minutes
analyzed by Radioimmunoassay, taken 15 minutes after having the breakfast with balance composition in both of the study arm
PYY levels at 60 minute
Time frame: 60 minutes
analyzed by Radioimmunoassay, taken 60 minutes after having the breakfast with balance composition in both of the study arm
PYY levels at 120 minute
Time frame: 120 minutes
analyzed by Radioimmunoassay, taken 120 minutes after having the breakfast with balance composition in both of the study arm
PYY levels at 180 minute
Time frame: 180 minutes
analyzed by Radioimmunoassay, taken 180 minutes after having the breakfast with balance composition in both of the study arm
GLP-1 levels at 0 minute
Time frame: baseline
analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm
GLP-1 levels at 15 minute
Time frame: 15 minutes
analyzed by ELISA, taken 15 minutes after having the breakfast with balance composition in both of the study arm
GLP-1 levels at 60 minute
Time frame: 60 minutes
analyzed by ELISA, taken 60 minutes after having the breakfast with balance composition in both of the study arm
GLP-1 levels at 120 minute
Time frame: 120 minutes
analyzed by ELISA, taken 120 minutes after having the breakfast with balance composition in both of the study arm
GLP-1 levels at 180 minute
Time frame: 180 minutes
analyzed by ELISA, taken 180 minutes after having the breakfast with balance composition in both of the study arm
Glucose levels at 0 minute
Time frame: baseline
analyzed by standard random glucose level from venous blood, directly taken after having the breakfast with balanced composition in both of the study arm
Glucose levels at 15 minute
Time frame: 15 minutes
analyzed by standard random glucose level from venous blood, taken 15 minutes after having the breakfast with balanced composition in both of the study arm
Glucose levels at 60 minute
Time frame: 60 minutes
analyzed by standard random glucose level from venous blood, taken 60 minutes after having the breakfast with balanced composition in both of the study arm
Glucose levels at 120 minute
Time frame: 120 minutes
analyzed by standard random glucose level from venous blood, taken 120 minutes after having the breakfast with balanced composition in both of the study arm
Glucose levels at 180 minute
Time frame: 180 minutes
analyzed by standard random glucose level from venous blood, taken 180 minutes after having the breakfast with balanced composition in both of the study arm
Ad Libitum intake
Time frame: 4 hours
Mean Ad Libitum intake (calories) in subjects four hours after breakfast with balance composition in both of the study arm
VAS for hunger at 0 minutes
Time frame: baseline
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 balance composition in both of the study arm
VAS for hunger at 15 minutes
Time frame: 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 balance composition in both of the study arm
VAS for hunger at 60 minutes
Time frame: 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 balance composition in both of the study arm
VAS for hunger at 120 minutes
Time frame: 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 balance composition in both of the study arm
VAS for hunger at 180 minutes
Time frame: 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 balance composition in both of the study arm
VAS for satiety at 0 minutes
Time frame: baseline
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 balance composition in both of the study arm
VAS for satiety at 15 minutes
Time frame: 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 balance composition in both of the study arm
VAS for satiety at 60 minutes
Time frame: 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 balance composition in both of the study arm
VAS for satiety at 120 minutes
Time frame: 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 balance composition in both of the study arm
VAS for satiety at 180 minutes
Time frame: 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 balance composition in both of the study arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for PYY
Recruiting
Rutazyme Lemon Fermented Product Capsules for Metabolic Function in Adults With Obesity
Obesity, Metabolic Syndrome
Enrolling by invitationPhase 2
Co-Feedback Action of Growth Hormone, PP and PYY on Ghrelin in Bulimia
Eating Disorder, Bulimia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women in people with PYY and Ghrelin, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ghrelin levels at 0 minute (time frame: baseline). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.