Effect of Premeal Protein-bar on Food Intake

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431233
• Other study ID #: H-1705-091-855
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

• 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)

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food intake	grams and caloric intake of standardized gimbap	120min
Secondary	Appetite (visual analogue scale : score 1 to 10)	(1: I am not hungry at all, 10: I have never been more hungry)	120min
Secondary	Satiety (visual analogue scale : score 1 to 10)		120min
Secondary	plasma glucose (mmol/L)	plasma level of glucose	-15min, 0(breakfast), 30, 60, 90, 120 min
Secondary	plasma active/total GLP-1 (pmol/L)	plasma level of active/total GLP-1	-15min, 0(breakfast), 30, 60, 90, 120 min
Secondary	plasma active ghrelin (ng/ml)	plasma level of active ghrelin	-15min, 0(breakfast), 30, 60, 90, 120 min
Secondary	plasma total peptide YY (pg/ml)	plasma level of peptide YY	-15min, 0(breakfast), 30, 60, 90, 120 min