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

NCT ID: NCT01997281

Last Updated: 2020-11-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Keywords

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dietary fiber diabetes mellitus gut hormone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

dietary fiber-enriched cereal

Intervention Type DIETARY_SUPPLEMENT

* 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

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

Group Type OTHER

conventional cereal

Intervention Type OTHER

* 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young Min Cho, MD, PHD

Role: STUDY_CHAIR

Seoul National University College of Medicine

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 26839476 (View on PubMed)

Other Identifiers

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0620132990

Identifier Type: OTHER

Identifier Source: secondary_id

H-1307-133-508

Identifier Type: -

Identifier Source: org_study_id