NCT03701503

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

October 8, 2018

Last Update Submit

October 8, 2018

Conditions

PYYGhrelinAppetiteGut HormonesObesityVAS of SatietyVAS of HungerGLP - 1

Outcome Measures

Primary Outcomes (31)

  • Ghrelin levels at 0 minute

    analyzed by ELISA, directly taken after having the breakfast with balance composition in both of the study arm.

    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.

    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.

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    180 minutes

Study Arms (2)

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.

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.

Behavioral: Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women

Interventions

Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese womenBEHAVIORAL
Non ObeseObese

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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

Study Sites (1)

Departement of Nutrition, Faculty of Medicine Universitas Indonesia

Jakarta, Jakarta Pusat, 10110, Indonesia

Location

MeSH Terms

Conditions

Obesity

Interventions

DietAdiposity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaBody Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolism

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 10, 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

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)