NCT01997281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

November 16, 2020

Completed
Last Updated

November 16, 2020

Status Verified

August 1, 2014

Enrollment Period

6 months

First QC Date

November 22, 2013

Results QC Date

August 28, 2019

Last Update Submit

October 22, 2020

Conditions

Diabetes Mellitus

Keywords

dietary fiberdiabetes mellitusgut hormone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

DF-cereal

EXPERIMENTAL

* 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

conventional cereal

OTHER

* 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

Interventions

dietary fiber-enriched cerealDIETARY_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

DF-cereal
conventional cerealOTHER

* 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

conventional cereal

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 26839476DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Youn Min Cho, M.D, PhD
Organization
Seoul National University College of Medicine
ymchomd@snu.ac.kr
+82-2-2072-1965

Study Officials

  • Young Min Cho, MD, PHD

    Seoul National University College of Medicine

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2013

First Posted

November 28, 2013

Study Start

December 1, 2013

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

November 16, 2020

Results First Posted

November 16, 2020

Record last verified: 2014-08

Locations

KR(1)