Effect of Premeal Protein-bar on Food Intake

NCT ID: NCT03431233

Last Updated: 2019-08-29

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-06-01

Brief Summary

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The aim of this study is to explore premeal protein-enriched bar effect in food intake in healthy subjects.

Detailed Description

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Twenty healthy subjects will be recruited. Every subject will be randomized in 6 groups and studied on 3 separate days in random order with 1 week intervals. These participants will consume protein enriched bar, commercial cereal bar, or water followed by a standardized diet (gimbap). For study outcomes, food intake, appetite and satiety (visual analog scale), plasma glucose, and satiety related hormone will be measured. Blood sampling will be done before 15 min of breakeast, at the moment of start of breakfast (0 min), and then 30, 60, 90, 120 min. Plasma glucose levels, total/active GLP-1, ghrelin, total PYY will be measured.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

protein enriched bar-\>commercial cereal bar-\>water

Group Type EXPERIMENTAL

Protein-enriched bar, commercial cereal bar, or water

Intervention Type DIETARY_SUPPLEMENT

Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.

Group 2

protein enriched bar-\>water-\>commercial cereal bar

Group Type EXPERIMENTAL

Protein-enriched bar, commercial cereal bar, or water

Intervention Type DIETARY_SUPPLEMENT

Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.

Group 3

commercial cereal bar-\>protein enriched bar-\>water

Group Type EXPERIMENTAL

Protein-enriched bar, commercial cereal bar, or water

Intervention Type DIETARY_SUPPLEMENT

Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.

Group 4

commercial cereal bar-\>water-\>protein enriched bar

Group Type EXPERIMENTAL

Protein-enriched bar, commercial cereal bar, or water

Intervention Type DIETARY_SUPPLEMENT

Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.

Group 5

water-\>protein enriched bar-\>commercial cereal bar

Group Type EXPERIMENTAL

Protein-enriched bar, commercial cereal bar, or water

Intervention Type DIETARY_SUPPLEMENT

Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.

Group 6

water-\>commercial cereal bar-\>protein enriched bar

Group Type EXPERIMENTAL

Protein-enriched bar, commercial cereal bar, or water

Intervention Type DIETARY_SUPPLEMENT

Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.

Interventions

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Protein-enriched bar, commercial cereal bar, or water

Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI 18.5\~35 kg/m2
* Never diagnosed by diabetes
* Fasting plasma glucose \<=100mg/dl and HbA1c \<6.0%

Exclusion Criteria

* Those who diagnosed by Type 1 or Type 2 diabetes
* Allergy to wheat, flour, nuts, milk
* Pregnancy/lactation
* AST or ALT \>2.5 times of upper normal reference range
* eGFR \<30 mL/min/1.73m2
* Hb \<10g/dl
* History of GI surgery (except hemorrhoidectomy, appendectomy)
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Min Cho

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Min Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1705-091-855

Identifier Type: -

Identifier Source: org_study_id

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