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Completed

NCT Number: NCT01997281

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dietary fiber-enriched cereal

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

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

Primary outcomes

  1. Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal

    Time frame: 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 outcomes

  1. AUC of Plasma Total GIP Levels After Intake of the Study Meal

    Time frame: every 30 minutes from 8 a.m. to noon on the second day

  2. AUC of Plasma Glucose Levels After Intake of the Study Meal

    Time frame: every 30 minutes from 8 a.m. to noon on the second day

  3. AUC of Plasma Insulin Levels After Intake of the Study Meal

    Time frame: every 30 minutes from 8 a.m. to noon on the second day

  4. AUC of Plasma Glucagon Levels After Intake of the Study Meal

    Time frame: every 30 minutes from 8 a.m. to noon on the second day

  5. AUC of Serum Free Fatty Acid Levels After Intake of the Study Meal

    Time frame: every 30 minutes from 8 a.m. to noon on the second day

  6. AUC of Plasma Total GIP Levels After Lunch

    Time frame: every 30 minutes from noon to 4 p.m. on the second day

  7. AUC of Plasma Glucose Levels After Lunch

    Time frame: every 30 minutes from noon to 4 p.m. on the second day

  8. AUC of Plasma Insulin Levels After Lunch

    Time frame: every 30 minutes from noon to 4 p.m. on the second day

  9. AUC of Plasma Glucagon Levels After Lunch

    Time frame: every 30 minutes from noon to 4 p.m. on the second day

  10. AUC of Serum Free Fatty Acid Levels After Lunch

    Time frame: every 30 minutes from noon to 4 p.m. on the second day

  11. AUC of Plasma Total GLP-1 Levels After Lunch

    Time frame: every 30 minutes from noon to 4 p.m. on the second day

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 28, 2013
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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