The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones

The aim of this study is to assess whether dietary fiber-enriched cereals effect on postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2 diabetes mellitus.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: dietary fiber-enriched cereal; Other: conventional cereal

Detailed Description

Fifteen subjects with type 2 diabetes mellitus will be provided with study meals based on either dietary fiber-enriched cereals or conventional cereals upon two separate admissions in a cross-over fashion. The study meals will be provided at 6 p.m. and 10 p.m. on the day of admission, and 8 a.m. on the next day. A hamburger with coke as mixed meal will be given for lunch at noon on the second day. Blood sampling will be done every 30 minutes from 8 a.m. to 4 p.m. on the second day. The plasma levels of glucose, GLP-1, GIP, insulin, glucagon, and free fatty acid will be measured.

• Study Type: Interventional
• Enrollment (Actual): 28
• 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: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• type 2 diabetes mellitus
• HbA1c 6.5~8.5%
• on life style modification or metformin monotherapy at the time of screening

Exclusion Criteria:

• on sulfonylurea or insulin therapy at the time of screening
• allergy to wheat, flour, other cereals or nuts
• lactose intolerance
• pregnancy / lactation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DF-cereal; dietary fiber-enriched cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.); amount of cereal: 79 g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.); one serving (40g) of steamed egg is added for dinner and breakfast	Dietary supplement: dietary fiber-enriched cereal; provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.); amount: 79g for dinner and breakfast, 38.5g for night snack (10 p.m.); one serving of steamed egg is added for dinner and breakfast
Other: conventional cereal; conventional cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.); amount of cereal: 80g (285.7 kcal) for dinner and breakfast, 40g (142.9 kcal) for night snack (10 p.m.); one serving (40g) of steamed egg is added for dinner and breakfast	Other: conventional cereal; provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.); amount: 80 g for dinner and breakfast, 40 g for night snack (10 p.m.); one serving (40g) of steamed egg is added for dinner and breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal	To see the changes in the secretion of GLP-1 with dietary fiber enriched cereal, we will calculate the AUC of the plasma total GLP-1 levels.	every 30 minutes from 8 a.m. to noon on the second day

Secondary Outcome Measures

Outcome Measure	Time Frame
AUC of Plasma Total GIP Levels After Intake of the Study Meal	every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Glucose Levels After Intake of the Study Meal	every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Insulin Levels After Intake of the Study Meal	every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Glucagon Levels After Intake of the Study Meal	every 30 minutes from 8 a.m. to noon on the second day
AUC of Serum Free Fatty Acid Levels After Intake of the Study Meal	every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Total GIP Levels After Lunch	every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Glucose Levels After Lunch	every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Insulin Levels After Lunch	every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Glucagon Levels After Lunch	every 30 minutes from noon to 4 p.m. on the second day
AUC of Serum Free Fatty Acid Levels After Lunch	every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Total GLP-1 Levels After Lunch	every 30 minutes from noon to 4 p.m. on the second day

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Young Min Cho, MD, PHD, Seoul National University College of Medicine

Publications and helpful links

General Publications

• Kim EK, Oh TJ, Kim LK, Cho YM. Improving Effect of the Acute Administration of Dietary Fiber-Enriched Cereals on Blood Glucose Levels and Gut Hormone Secretion. J Korean Med Sci. 2016 Feb;31(2):222-30. doi: 10.3346/jkms.2016.31.2.222. Epub 2016 Jan 26.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Actual): November 16, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: diabetes mellitus; dietary fiber; gut hormone
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: H-1307-133-508; 0620132990 (Other Identifier: SNUH Institutional Review Board)