Effect of Premeal Protein-bar on Food Intake

Seoul National University Hospital20 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Subjects

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

* 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)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Food intake

grams and caloric intake of standardized gimbap

Time frame: 120min

Secondary Outcomes

Appetite (visual analogue scale : score 1 to 10)

(1: I am not hungry at all, 10: I have never been more hungry)

Time frame: 120min

Satiety (visual analogue scale : score 1 to 10)

Time frame: 120min

plasma glucose (mmol/L)

plasma level of glucose

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

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

plasma level of active/total GLP-1

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

plasma active ghrelin (ng/ml)

plasma level of active ghrelin

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

plasma total peptide YY (pg/ml)

plasma level of peptide YY

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.