Trial Outcomes & Findings for Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes (NCT NCT02180646)
NCT ID: NCT02180646
Last Updated: 2019-10-03
Results Overview
AUC for 4 hr after breakfast and after lunch
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
0-240 and 240-480
Results posted on
2019-10-03
Participant Flow
Participant milestones
| Measure |
High Carb Then High Protein Breakfast
A high carbohydrate breakfast for 7 days, followed by a 7-day washout, followed a high protein breakfast for 7 days
|
High Protein Then High Carb Breakfast
A high protein breakfast for 7 days, followed by a 7-day washout, followed a high carbohydrate breakfast for 7 days
|
|---|---|---|
|
First Intervention (7 Days)
STARTED
|
6
|
6
|
|
First Intervention (7 Days)
COMPLETED
|
6
|
6
|
|
First Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (7 Days)
STARTED
|
6
|
6
|
|
Washout (7 Days)
COMPLETED
|
6
|
6
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (7 Days)
STARTED
|
6
|
6
|
|
Second Intervention (7 Days)
COMPLETED
|
6
|
6
|
|
Second Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
High Carb Then High Protein Breakfast
n=6 Participants
A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) for 7 days, followed by 7-day washout, followed by a high protein breakfast for 7 days
|
High Protein Then High Carb Breakfast
n=6 Participants
A high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) for 7 days, followed by a 7-day washout, followed by a high carbohydrate breakfast for 7 days
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-240 and 240-480AUC for 4 hr after breakfast and after lunch
Outcome measures
| Measure |
High Protein Breakfast
n=12 Participants
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast
|
High Carbohydrate Breakfast
n=12 Participants
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast
|
|---|---|---|
|
Plasma Glucose Level Post-meal (AUC [0-4])
|
28426 min*pg/ml
Standard Error 1660
|
33911 min*pg/ml
Standard Error 2590
|
SECONDARY outcome
Timeframe: 0-240 and 240-480AUC for 4 hr after breakfast and after lunch
Outcome measures
| Measure |
High Protein Breakfast
n=12 Participants
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast
|
High Carbohydrate Breakfast
n=12 Participants
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast
|
|---|---|---|
|
Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)
|
15156 min*pg/ml
Standard Error 3100
|
14620 min*pg/ml
Standard Error 1814
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-240 and 240-480AUC for 4 hr after breakfast and after lunch
Outcome measures
| Measure |
High Protein Breakfast
n=12 Participants
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast
|
High Carbohydrate Breakfast
n=12 Participants
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast
|
|---|---|---|
|
Post-meal Insulin Level (AUC [0-4])
|
428869 min*pg/ml
Standard Error 55831
|
474236 min*pg/ml
Standard Error 53518
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-240 and 240-480AUC for 4 hr after breakfast and after lunch
Outcome measures
| Measure |
High Protein Breakfast
n=12 Participants
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast
|
High Carbohydrate Breakfast
n=12 Participants
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
high protein breakfast
high carbohydrate breakfast
|
|---|---|---|
|
Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC )
|
14 ng/ml x min for 4 h
Standard Error 3.1
|
11.5 ng/ml x min for 4 h
Standard Error 2
|
Adverse Events
High Protein Breakfast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Carbohydrate Breakfast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place