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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997281
• Other study ID #: H-1307-133-508
• Secondary ID: 0620132990
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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
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

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