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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03697486
Other study ID # GuthormonesS3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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