Effect of Premeal Protein-bar on Food Intake

Study Overview
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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.

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein-enriched bar, food intake, appetite, satiety related hormones