Clinical trial NCT03697486: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PYY
Ghrelin
Appetite
Gut Hormones
Obesity
Protein Consumption
Keywords: PYY
ghrelin
ad libitum intake
high protein diet
moderately protein diet
low protein diet
breakfast
obesity
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: SEAMEO Regional Centre for Food and Nutrition
name: Dr Cipto Mangunkusumo General Hospital
First posted: 2018-10-05
Enrollment: 22
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ghrelin levels at 0 minute
timeFrame: baseline
measure: Ghrelin levels at 15 minute
timeFrame: 15 minutes
measure: Ghrelin levels at 60 minute
timeFrame: 60 minutes
measure: Ghrelin levels at 120 minute
timeFrame: 120 minutes
measure: Ghrelin levels at 180 minute
timeFrame: 180 minutes
measure: PYY levels at 0 minute
timeFrame: baseline
measure: PYY levels at 15 minute
timeFrame: 15 minutes
measure: PYY levels at 60 minute
timeFrame: 60 minutes
measure: PYY levels at 120 minute
timeFrame: 120 minutes
measure: PYY levels at 180 minute
timeFrame: 180 minutes
measure: GLP-1 levels at 0 minute
timeFrame: baseline
measure: GLP-1 levels at 15 minute
timeFrame: 15 minutes
measure: GLP-1 levels at 60 minute
timeFrame: 60 minutes
measure: GLP-1 levels at 120 minute
timeFrame: 120 minutes
measure: GLP-1 levels at 180 minute
timeFrame: 180 minutes
measure: Glucose levels at 0 minute
timeFrame: baseline
measure: Glucose levels at 15 minute
timeFrame: 15 minutes
measure: Glucose levels at 60 minute
timeFrame: 60 minutes
measure: Glucose levels at 120 minute
timeFrame: 120 minutes
measure: Glucose levels at 180 minute
timeFrame: 180 minutes
measure: Ad Libitum intake
timeFrame: 4 hours
measure: VAS for hunger at 0 minutes
timeFrame: baseline
measure: VAS for hunger at 15 minutes
timeFrame: 15 minutes
measure: VAS for hunger at 60 minutes
timeFrame: 60 minutes
measure: VAS for hunger at 120 minutes
timeFrame: 120 minutes
measure: VAS for hunger at 180 minutes
timeFrame: 180 minutes
measure: VAS for satiety at 0 minute
timeFrame: baseline
measure: VAS for satiety at 15 minute
timeFrame: 15 minutes
measure: VAS for satiety at 60 minute
timeFrame: 60 minutes
measure: VAS for satiety at 120 minute
timeFrame: 120 minutes
measure: VAS for satiety at 180 minute
timeFrame: 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Departement of Nutrition, Faculty of Medicine Universitas Indonesia
state: Jakarta Pusat
Study officials:
References:
citation: 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.