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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01997281

Enrollment

Registered

2013-11-28

Start date

2013-12-31

Completion date

2014-08-31

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

dietary fiber, diabetes mellitus, gut hormone

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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTdietary 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

OTHERconventional 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal	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

Measure	Time frame
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 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 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
AUC of Plasma Glucose Levels After Lunch	every 30 minutes from noon to 4 p.m. on the second day

Countries

South Korea

Participant flow

Participants by arm

Arm	Count
DF-cereal, Then Conventional Cereal * Dietary fiber-enriched cereal was provided with 300 mL of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.) * amount of cereal: 79g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.) * one serving (40g) of steamed egg was added for dinner and breakfast after 1 week of wash-out period, subjects were re-admitted * Conventional cereal was provided with 300 ml of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 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 wass added for dinner and breakfast	6
Conventional Cereal, Then DF-cereal * Conventional cereal was provided with 300 ml of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 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 wass added for dinner and breakfast after 1 week of wash-out period, subjects were re-admitted * Dietary fiber-enriched cereal was provided with 300 mL of milk, total 3 times (Day 1 at 6 p.m. and 10 p.m., Day 2 at 8 a.m.) * amount of cereal: 79g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.) * one serving (40g) of steamed egg was added for dinner and breakfast	7
Total	13

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Conventional Cereal, Then DF-cereal	Total	DF-cereal, Then Conventional Cereal
Age, Continuous	55.2 years STANDARD_DEVIATION 8	55.2 years STANDARD_DEVIATION 8	55.2 years STANDARD_DEVIATION 8
Body Mass Index (BMI)	25.0 kg/m^2 STANDARD_DEVIATION 3.7	23.7 kg/m^2 STANDARD_DEVIATION 2.9	22.2 kg/m^2 STANDARD_DEVIATION 2
HbA1c	6.7 % of glycated hemoglobin STANDARD_DEVIATION 0.3	6.8 % of glycated hemoglobin STANDARD_DEVIATION 0.5	6.9 % of glycated hemoglobin STANDARD_DEVIATION 0.7
Region of Enrollment South Korea	7 participants	13 participants	6 participants
Sex: Female, Male Female	5 Participants	9 Participants	4 Participants
Sex: Female, Male Male	2 Participants	4 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 13	0 / 13
other Total, other adverse events	7 / 13	0 / 13
serious Total, serious adverse events	0 / 13	0 / 13

Outcome results

Primary

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.

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

Arm	Measure	Value (MEAN)	Dispersion
DF-cereal	Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal	10.5 pM x hr/L	Standard Deviation 1.9
Conventional Cereal	Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal	10.5 pM x hr/L	Standard Deviation 1.6

Secondary