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

Seoul National University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: conventional cereal; Dietary Supplement: dietary fiber-enriched cereal

Study type: Interventional

Funder types: Other

Identifiers

NCT01997281

0620132990 (Other Identifier)

H-1307-133-508

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

DF-cereal

Experimental group

Description:

* 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

Treatment:

Dietary Supplement: dietary fiber-enriched cereal

conventional cereal

Other group

Description:

* 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

Treatment:

Other: conventional cereal