Trial Outcomes & Findings for The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones (NCT NCT01997281)
NCT ID: NCT01997281
Last Updated: 2020-11-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
every 30 minutes from 8 a.m. to noon on the second day
Results posted on
2020-11-16
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
Withdrawal
|
1
|
0
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones
Baseline characteristics by cohort
| Measure |
DF-cereal, Then Conventional Cereal
n=6 Participants
* 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
|
Conventional Cereal, Then DF-cereal
n=7 Participants
* 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
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
22.2 kg/m^2
STANDARD_DEVIATION 2.0 • n=5 Participants
|
25.0 kg/m^2
STANDARD_DEVIATION 3.7 • n=7 Participants
|
23.7 kg/m^2
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
HbA1c
|
6.9 % of glycated hemoglobin
STANDARD_DEVIATION 0.7 • n=5 Participants
|
6.7 % of glycated hemoglobin
STANDARD_DEVIATION 0.3 • n=7 Participants
|
6.8 % of glycated hemoglobin
STANDARD_DEVIATION 0.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: every 30 minutes from 8 a.m. to noon on the second dayTo 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.
Outcome measures
| Measure |
DF-cereal
n=13 Participants
* 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 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
|
Conventional Cereal
n=13 Participants
* 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
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
|
|---|---|---|
|
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
|
10.5 pM x hr/L
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: every 30 minutes from 8 a.m. to noon on the second dayOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 30 minutes from 8 a.m. to noon on the second dayOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 30 minutes from 8 a.m. to noon on the second dayOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 30 minutes from 8 a.m. to noon on the second dayOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 30 minutes from 8 a.m. to noon on the second dayOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 30 minutes from noon to 4 p.m. on the second dayOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 30 minutes from noon to 4 p.m. on the second dayOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 30 minutes from noon to 4 p.m. on the second dayOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 30 minutes from noon to 4 p.m. on the second dayOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 30 minutes from noon to 4 p.m. on the second dayOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 30 minutes from noon to 4 p.m. on the second dayOutcome measures
Outcome data not reported
Adverse Events
DF-cereal
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Conventional Cereal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DF-cereal
n=13 participants at risk
* 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
|
Conventional Cereal
n=13 participants at risk
* 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
|
|---|---|---|
|
Gastrointestinal disorders
abdominal discomfort
|
30.8%
4/13
The definition of adverse event and serious adverse event was not differ from clinicaltrials.gov definitions.
|
0.00%
0/13
The definition of adverse event and serious adverse event was not differ from clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
increased gas-out
|
15.4%
2/13
The definition of adverse event and serious adverse event was not differ from clinicaltrials.gov definitions.
|
0.00%
0/13
The definition of adverse event and serious adverse event was not differ from clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
increased amount and number of defecation
|
7.7%
1/13
The definition of adverse event and serious adverse event was not differ from clinicaltrials.gov definitions.
|
0.00%
0/13
The definition of adverse event and serious adverse event was not differ from clinicaltrials.gov definitions.
|
Additional Information
Youn Min Cho, M.D, PhD
Seoul National University College of Medicine
Phone: +82-2-2072-1965
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place