Trial Outcomes & Findings for The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses (NCT NCT03424187)
NCT ID: NCT03424187
Last Updated: 2021-04-02
Results Overview
Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal. Data were not collected for intact cell chickpea hummus
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.
Results posted on
2021-04-02
Participant Flow
this study was a randomized crossover study
Participant milestones
| Measure |
Experimental: Whole Chickpea First, Then Flour Chickpea, Then Intact Cell Chickpea
First intervention whole chickpea hummus (26g carbohydrate), washout (1 week), Second Flour chickpea hummus (26g carbohydrate), washout (1 week), Third Intact Cell Chickpea hummus (26g carbohydrate)
|
Experimental: Whole Chickpea First, Then Intact Cell Chickpea, Then Flour Chickpea
First intervention whole chickpea hummus (26g carbohydrate), washout (1 week), Second Intact Cell Chickpea hummus (26g carbohydrate), washout (1 week), Third Flour chickpea hummus (26g carbohydrate)
|
Experimental:Flour Chickpea First, Then Whole Chickpea, Then Intact Chickpea
First intervention Flour chickpea hummus (26g carbohydrate), washout (1 week), Second whole Chickpea hummus (26g carbohydrate), washout (1 week), Third Intact Cell hummus (26g carbohydrate)
|
Experimental: Flour Chickpea First, Intact Cell Chickpea, Whole Chickpea
First intervention Flour chickpea hummus (26g carbohydrate), washout (1 week), Second Intact Cell Chickpea hummus (26g carbohydrate), washout (1 week), Third whole chickpea hummus (26g carbohydrate)
|
Experimental: Intact Cell Chickpea First, Then Whole Chickpea, Then Flour Chickpea
First intervention Intact Cell hummus (26g carbohydrate), washout (1 week), Second whole Chickpea hummus (26g carbohydrate), washout (1 week), Third Flour chickpea hummus (26g carbohydrate)
|
Experimental: Intact Cell Chickpea First, Then Flour Chickpea, Then Whole Chickpea
First intervention Intact Cell hummus (26g carbohydrate), washout (1 week), Second flour Chickpea hummus (26g carbohydrate), washout (1 week), Third whole chickpea hummus (26g carbohydrate)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
2
|
3
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
3
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental: Whole Chickpea First, Then Flour Chickpea, Then Intact Cell Chickpea
n=2 Participants
First intervention whole chickpea hummus (26g carbohydrate), washout (1 week), Second Flour chickpea hummus (26g carbohydrate), washout (1 week), Third Intact Cell Chickpea hummus (26g carbohydrate)
|
Experimental: Whole Chickpea First, Then Intact Cell Chickpea, Then Flour Chickpea
n=3 Participants
First intervention whole chickpea hummus (26g carbohydrate), washout (1 week), Second Intact Cell Chickpea hummus (26g carbohydrate), washout (1 week), Third Flour chickpea hummus (26g carbohydrate
|
Experimental:Flour Chickpea First, Then Whole Chickpea, Then Intact Chickpea
n=2 Participants
First intervention Flour chickpea hummus (26g carbohydrate), washout (1 week), Second whole Chickpea hummus (26g carbohydrate), washout (1 week), Third Intact Cell hummus (26g carbohydrate)
|
Experimental: Flour Chickpea First, Intact Cell Chickpea, Whole Chickpea
n=3 Participants
First intervention Flour chickpea hummus (26g carbohydrate), washout (1 week), Second Intact Cell Chickpea hummus (26g carbohydrate), washout (1 week), Third whole chickpea hummus (26g carbohydrate)
|
Experimental: Intact Cell Chickpea First, Then Whole Chickpea, Then Flour Chickpea
n=2 Participants
First intervention Intact Cell hummus (26g carbohydrate), washout (1 week), Second whole Chickpea hummus (26g carbohydrate), washout (1 week), Third Flour chickpea hummus (26g carbohydrate)
|
Experimental: Intact Cell Chickpea First, Then Flour Chickpea, Then Whole Chickpea
n=3 Participants
First intervention Intact Cell hummus (26g carbohydrate), washout (1 week), Second flour Chickpea hummus (26g carbohydrate), washout (1 week), Third whole chickpea hummus (26g carbohydrate)
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
15 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
10 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.Population: Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus only. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal. Data were not collected for intact cell chickpea hummus
Outcome measures
| Measure |
Whole Chickpea
n=15 Participants
a test meal containing 26g available carbohydrates from chickpea (full structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
Flour Chickpea
n=15 Participants
a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
Intact Cell Chickpea Hummus
a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
|---|---|---|---|
|
Post-prandial Glucose Concentrations
time point 0
|
4.9 mmol/l
Standard Deviation 0.48
|
4.8 mmol/l
Standard Deviation 0.31
|
—
|
|
Post-prandial Glucose Concentrations
Time point 15
|
4.9 mmol/l
Standard Deviation 0.53
|
5.01 mmol/l
Standard Deviation 0.38
|
—
|
|
Post-prandial Glucose Concentrations
Time point 30
|
5.1 mmol/l
Standard Deviation 0.57
|
5.4 mmol/l
Standard Deviation 0.53
|
—
|
|
Post-prandial Glucose Concentrations
Time point 60
|
5.08 mmol/l
Standard Deviation 0.78
|
4.9 mmol/l
Standard Deviation 0.87
|
—
|
|
Post-prandial Glucose Concentrations
Time point 90
|
5.07 mmol/l
Standard Deviation 0.73
|
4.8 mmol/l
Standard Deviation 0.6
|
—
|
|
Post-prandial Glucose Concentrations
Time point 120
|
5.18 mmol/l
Standard Deviation 0.56
|
4.9 mmol/l
Standard Deviation 0.4
|
—
|
|
Post-prandial Glucose Concentrations
Time point 180
|
5.14 mmol/l
Standard Deviation 0.46
|
5.1 mmol/l
Standard Deviation 0.44
|
—
|
PRIMARY outcome
Timeframe: before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal.Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
Outcome measures
| Measure |
Whole Chickpea
n=15 Participants
a test meal containing 26g available carbohydrates from chickpea (full structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
Flour Chickpea
n=15 Participants
a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
Intact Cell Chickpea Hummus
n=15 Participants
a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
|---|---|---|---|
|
Post-prandial Blood Insulin Concentrations
0 minutes
|
9.3 uU/ml
Standard Deviation 4.03
|
10.3 uU/ml
Standard Deviation 5.4
|
8.8 uU/ml
Standard Deviation 5.4
|
|
Post-prandial Blood Insulin Concentrations
15 minutes
|
16.8 uU/ml
Standard Deviation 9.6
|
20 uU/ml
Standard Deviation 10.9
|
26.24 uU/ml
Standard Deviation 19.6
|
|
Post-prandial Blood Insulin Concentrations
30 minutes
|
29.3 uU/ml
Standard Deviation 12.5
|
37.5 uU/ml
Standard Deviation 17.3
|
43.1 uU/ml
Standard Deviation 26
|
|
Post-prandial Blood Insulin Concentrations
60 minutes
|
29.1 uU/ml
Standard Deviation 20.4
|
36.5 uU/ml
Standard Deviation 24.2
|
37.9 uU/ml
Standard Deviation 23.2
|
|
Post-prandial Blood Insulin Concentrations
90 minutes
|
24.3 uU/ml
Standard Deviation 15.8
|
31.6 uU/ml
Standard Deviation 17.12
|
33.7 uU/ml
Standard Deviation 13.8
|
|
Post-prandial Blood Insulin Concentrations
120 minutes
|
12.4 uU/ml
Standard Deviation 14.2
|
34.1 uU/ml
Standard Deviation 24.5
|
36.5 uU/ml
Standard Deviation 31.1
|
|
Post-prandial Blood Insulin Concentrations
180 minutes
|
14.9 uU/ml
Standard Deviation 8.5
|
16.8 uU/ml
Standard Deviation 7.4
|
17.57 uU/ml
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes.Blood GIP concentrations were assessed for each participant after each test meal: whole chickpea hummus, and Flour chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal. Data were not collected for intact cell chickpea hummus
Outcome measures
| Measure |
Whole Chickpea
n=15 Participants
a test meal containing 26g available carbohydrates from chickpea (full structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
Flour Chickpea
n=15 Participants
a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
Intact Cell Chickpea Hummus
a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
|---|---|---|---|
|
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
baseline 0 minutes
|
43.02 pmol/L
Standard Deviation 23.07
|
47 pmol/L
Standard Deviation 20.6
|
—
|
|
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
15 min
|
102.6 pmol/L
Standard Deviation 34.47
|
181.3 pmol/L
Standard Deviation 97.3
|
—
|
|
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
30 min
|
343.7 pmol/L
Standard Deviation 166.9
|
516.2 pmol/L
Standard Deviation 217.9
|
—
|
|
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
60 min
|
508 pmol/L
Standard Deviation 186.8
|
651 pmol/L
Standard Deviation 220
|
—
|
|
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
90 min
|
509 pmol/L
Standard Deviation 199.5
|
601.9 pmol/L
Standard Deviation 199
|
—
|
|
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
120 min
|
466.48 pmol/L
Standard Deviation 171.32
|
562.033 pmol/L
Standard Deviation 172.6
|
—
|
|
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
180 min
|
378.1 pmol/L
Standard Deviation 153.9
|
440.7 pmol/L
Standard Deviation 199.4
|
—
|
SECONDARY outcome
Timeframe: baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal.Blood GLP-1 concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
Outcome measures
| Measure |
Whole Chickpea
n=15 Participants
a test meal containing 26g available carbohydrates from chickpea (full structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
Flour Chickpea
n=15 Participants
a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
Intact Cell Chickpea Hummus
n=15 Participants
a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
|---|---|---|---|
|
Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
180 min
|
103.9 pmol/l
Standard Deviation 57.7
|
109.2 pmol/l
Standard Deviation 53
|
92.9 pmol/l
Standard Deviation 49.4
|
|
Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
baseline
|
67.3 pmol/l
Standard Deviation 27.1
|
85.3 pmol/l
Standard Deviation 36.5
|
80.8 pmol/l
Standard Deviation 31.2
|
|
Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
15 min
|
122.8 pmol/l
Standard Deviation 63.3
|
98.7 pmol/l
Standard Deviation 49.3
|
91.7 pmol/l
Standard Deviation 34.2
|
|
Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
30 min
|
108.8 pmol/l
Standard Deviation 59.5
|
110.7 pmol/l
Standard Deviation 33
|
123.2 pmol/l
Standard Deviation 45.8
|
|
Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
60 min
|
113.5 pmol/l
Standard Deviation 39.4
|
115.5 pmol/l
Standard Deviation 43.2
|
128 pmol/l
Standard Deviation 42
|
|
Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
90 min
|
134.5 pmol/l
Standard Deviation 65.7
|
119 pmol/l
Standard Deviation 37.5
|
120.3 pmol/l
Standard Deviation 66.5
|
|
Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
120 min
|
114.6 pmol/l
Standard Deviation 77
|
130.9 pmol/l
Standard Deviation 57.6
|
108 pmol/l
Standard Deviation 46.4
|
SECONDARY outcome
Timeframe: post consumption of the test meal at 120 minutesThe difference in ad libitum food intake after 210 minutes post test meal to test the difference of energy intake following whole chickpea hummus, flour chickpea hummus, and intact cell chickpea hummus.
Outcome measures
| Measure |
Whole Chickpea
n=15 Participants
a test meal containing 26g available carbohydrates from chickpea (full structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
Flour Chickpea
n=15 Participants
a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
Intact Cell Chickpea Hummus
n=15 Participants
a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)
chickpea: all three meals are isocaloric but different in the chickpea structure( physical form):
• Whole chickpea, flour chickpea, intact cell flour chickpea
|
|---|---|---|---|
|
Energy Intake at a Meal Given in Excess
|
628.03 Kcal
Standard Deviation 321.7
|
681.9 Kcal
Standard Deviation 326
|
724.7 Kcal
Standard Deviation 308.3
|
Adverse Events
Whole Chickpea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flour Chickpea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intact Cell Chickpea
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