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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: dietary fiber-enriched cereal
* Other: conventional cereal


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DF-cereal<br>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<br>* 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<br>|
| Other: conventional cereal<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| AUC of Plasma Total GIP Levels After Lunch |  | every 30 minutes from noon to 4 p.m. on the second day | 
| AUC of Plasma Glucose Levels After Lunch |  | every 30 minutes from noon to 4 p.m. on the second day | 
| AUC of Plasma Insulin Levels After Lunch |  | every 30 minutes from noon to 4 p.m. on the second day | 
| AUC of Plasma Glucagon Levels After Lunch |  | every 30 minutes from noon to 4 p.m. on the second day | 
| AUC of Serum Free Fatty Acid Levels After Lunch |  | every 30 minutes from noon to 4 p.m. on the second day | 
| AUC of Plasma Total GLP-1 Levels After Lunch |  | every 30 minutes from noon to 4 p.m. on the second day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary fiber, diabetes mellitus, gut hormone