Effect of Premeal Protein-bar on Food Intake

An Exploratory Study of the Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Food Intake in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Dietary supplement: Protein-enriched bar, commercial cereal bar, or water

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; protein enriched bar->commercial cereal bar->water	Dietary supplement: Protein-enriched bar, commercial cereal bar, or water; Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.
Experimental: Group 2; protein enriched bar->water->commercial cereal bar	Dietary supplement: Protein-enriched bar, commercial cereal bar, or water; Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.
Experimental: Group 3; commercial cereal bar->protein enriched bar->water	Dietary supplement: Protein-enriched bar, commercial cereal bar, or water; Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.
Experimental: Group 4; commercial cereal bar->water->protein enriched bar	Dietary supplement: Protein-enriched bar, commercial cereal bar, or water; Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.
Experimental: Group 5; water->protein enriched bar->commercial cereal bar	Dietary supplement: Protein-enriched bar, commercial cereal bar, or water; Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.
Experimental: Group 6; water->commercial cereal bar->protein enriched bar	Dietary supplement: Protein-enriched bar, commercial cereal bar, or water; Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food intake	grams and caloric intake of standardized gimbap	120min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite (visual analogue scale : score 1 to 10)	(1: I am not hungry at all, 10: I have never been more hungry)	120min
Satiety (visual analogue scale : score 1 to 10)		120min
plasma glucose (mmol/L)	plasma level of glucose	-15min, 0(breakfast), 30, 60, 90, 120 min
plasma active/total GLP-1 (pmol/L)	plasma level of active/total GLP-1	-15min, 0(breakfast), 30, 60, 90, 120 min
plasma active ghrelin (ng/ml)	plasma level of active ghrelin	-15min, 0(breakfast), 30, 60, 90, 120 min
plasma total peptide YY (pg/ml)	plasma level of peptide YY	-15min, 0(breakfast), 30, 60, 90, 120 min

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: appetite; food intake; protein-enriched bar; satiety related hormones
• Other Study ID Numbers: H-1705-091-855

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No