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

NCT ID: NCT03701503

Last Updated: 2018-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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PYY Ghrelin Appetite Gut Hormones Obesity VAS of Satiety VAS of Hunger GLP - 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Obese

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Non Obese

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

Interventions

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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SEAMEO Regional Centre for Food and Nutrition

OTHER

Sponsor Role collaborator

Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role collaborator

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Fiastuti Witjaksono

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Departement of Nutrition, Faculty of Medicine Universitas Indonesia

Jakarta, Jakarta Pusat, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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GuthormoneOB-NonOB

Identifier Type: -

Identifier Source: org_study_id

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