Effect of Premeal Protein-bar on Food Intake

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

• Registration Number: NCT03431233
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-13
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Protein-enriched bar, commercial cereal bar, or water	protein enriched bar-\>water-\>commercial cereal bar
Group 4	Protein-enriched bar, commercial cereal bar, or water	commercial cereal bar-\>water-\>protein enriched bar
Group 1	Protein-enriched bar, commercial cereal bar, or water	protein enriched bar-\>commercial cereal bar-\>water
Group 3	Protein-enriched bar, commercial cereal bar, or water	commercial cereal bar-\>protein enriched bar-\>water
Group 5	Protein-enriched bar, commercial cereal bar, or water	water-\>protein enriched bar-\>commercial cereal bar
Group 6	Protein-enriched bar, commercial cereal bar, or water	water-\>commercial cereal bar-\>protein enriched bar

Primary Outcome Measures

Name	Time	Method
Food intake	120min	grams and caloric intake of standardized gimbap

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of