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

NCT ID: NCT03697486

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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PYY Ghrelin Appetite Gut Hormones Obesity Protein Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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High Protein

(40,6% protein)

Group Type EXPERIMENTAL

diet with different composition

Intervention Type BEHAVIORAL

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.

Moderate Protein

(23.5% protein)

Group Type EXPERIMENTAL

diet with different composition

Intervention Type BEHAVIORAL

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.

Low Protein

(12.4% protein)

Group Type EXPERIMENTAL

diet with different composition

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
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

References

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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.

Reference Type DERIVED
PMID: 30390699 (View on PubMed)

Other Identifiers

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GuthormonesS3

Identifier Type: -

Identifier Source: org_study_id

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