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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Dietary Supplement: dietary fiber-enriched cereal; Other: conventional cereal

• Registration Number: NCT01997281
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-28
• Study Start: 2013-12
• Primary Completion: 2014-06
• Status Verified: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2019-08-28
• Results First Submitted QC: 2020-10-22
• Last Update Submitted: 2020-10-22
• Results First Posted: 2020-11-16
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DF-cereal	dietary fiber-enriched 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
conventional cereal	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

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal	every 30 minutes from 8 a.m. to noon on the second day	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.

Secondary Outcome Measures

Name	Time	Method
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 Lunch	every 30 minutes from noon to 4 p.m. 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 Total GLP-1 Levels After Lunch	every 30 minutes from noon to 4 p.m. on the second day
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 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 Serum Free Fatty Acid Levels After Lunch	every 30 minutes from noon to 4 p.m. 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 Plasma Insulin Levels After Lunch	every 30 minutes from noon to 4 p.m. on the second day

Trial Locations

Locations (1)

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