NCT03431233

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration 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

August 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 29, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

January 15, 2018

Last Update Submit

August 28, 2019

Conditions

Healthy Subjects

Keywords

protein-enriched barfood intakeappetitesatiety related hormones

Outcome Measures

Primary Outcomes (1)

  • Food intake

    grams and caloric intake of standardized gimbap

    120min

Secondary Outcomes (6)

  • Appetite (visual analogue scale : score 1 to 10)

    120min

  • Satiety (visual analogue scale : score 1 to 10)

    120min

  • plasma glucose (mmol/L)

    -15min, 0(breakfast), 30, 60, 90, 120 min

  • plasma active/total GLP-1 (pmol/L)

    -15min, 0(breakfast), 30, 60, 90, 120 min

  • plasma active ghrelin (ng/ml)

    -15min, 0(breakfast), 30, 60, 90, 120 min

  • +1 more secondary outcomes

Study Arms (6)

Group 1

EXPERIMENTAL

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

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Group 2

EXPERIMENTAL

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

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Group 3

EXPERIMENTAL

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

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Group 4

EXPERIMENTAL

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

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Group 5

EXPERIMENTAL

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

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Group 6

EXPERIMENTAL

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

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Interventions

Protein-enriched bar, commercial cereal bar, or waterDIETARY_SUPPLEMENT

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

Group 1Group 2Group 3Group 4Group 5Group 6

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Young Min Cho, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2018

First Posted

February 13, 2018

Study Start

August 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

August 29, 2019

Record last verified: 2019-08

Locations

KR(1)