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Aims: To investigate the effects of different food structures on glucose concentrations and subsequent metabolic responses including insulin,GIP, GLP-1 DESIGN: A randomised, controlled, clinical trial.
Rationale:
There is very little evidence at the present time in the role of food structure in glucose homeostasis. There is circumstantial evidence that foods consumed intact have great effects on suppressing appetite.
To test the effect of three structurally different meals with the same nutritional content and volume on appetite regulation. Each participant will receive the following meals:
Solid meal group. Milled (intact-cell) meal group. Milled (destroyed-cell) meal group.
All of which will contain the same macro and micro nutrients from the same food sources
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| whole chickpea | Experimental | a test meal containing 26g available carbohydrates from chickpea (full structure) |
|
| flour chickpea | Experimental | a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure) |
|
| intact cell chickpea | Experimental | a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chickpea | Dietary Supplement | all three meals are isocaloric but different in the chickpea structure( physical form): • Whole chickpea, flour chickpea, intact cell flour chickpea |
| Measure | Description | Time Frame |
|---|---|---|
| Post-prandial Glucose Concentrations | 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 | before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal. |
| Post-prandial Blood Insulin Concentrations | 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. | before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38823849 | Derived | Alshaalan RA, Charalambides MN, Edwards CH, Ellis PR, Alrabeah SH, Frost GS. Impact of chickpea hummus on postprandial blood glucose, insulin and gut hormones in healthy humans combined with mechanistic studies of food structure, rheology and digestion kinetics. Food Res Int. 2024 Jul;188:114517. doi: 10.1016/j.foodres.2024.114517. Epub 2024 May 10. |
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this study was a randomized crossover study
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | 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) |
| FG003 | 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) |
| FG004 | 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) |
| FG005 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-prandial Glucose Concentrations | 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 | 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. | Posted | Mean | Standard Deviation | mmol/l | before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal. |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Whole Chickpea | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Frost | Imperial College London | +44 20 7594 0959 | g.frost@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2017 | Jul 7, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 18, 2015 | Jul 7, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C475601 | cicerin protein, Cicer arietinum |
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| before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes. |
| Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 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. | baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal. |
| Energy Intake at a Meal Given in Excess | The 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. | post consumption of the test meal at 120 minutes |
| 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 |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | 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) |
| BG005 | 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) |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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
| OG001 | Flour Chickpea | 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 |
|
|
| Primary | Post-prandial Blood Insulin Concentrations | 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. | Posted | Mean | Standard Deviation | uU/ml | before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal. |
|
|
|
| Secondary | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 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 | Posted | Mean | Standard Deviation | pmol/L | before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes. |
|
|
|
| Secondary | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 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. | Posted | Mean | Standard Deviation | pmol/l | baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal. |
|
|
|
| Secondary | Energy Intake at a Meal Given in Excess | The 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. | Posted | Mean | Standard Deviation | Kcal | post consumption of the test meal at 120 minutes |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Flour Chickpea | 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 | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Intact Cell Chickpea | 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 | 0 | 15 | 0 | 15 | 0 | 15 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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| 30 minutes |
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| 60 minutes |
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| 90 minutes |
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| 120 minutes |
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| 180 minutes |
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| 30 min |
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| 60 min |
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| 90 min |
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| 120 min |
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| 180 min |
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| 30 min |
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| 60 min |
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| 90 min |
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| 120 min |
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| 180 min |
|