Obesity
Conditions
Brief summary
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.
Detailed description
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
Interventions
DIETARY_SUPPLEMENTchickpea
all three meals are isocaloric but different in the chickpea structure( physical form): • Whole chickpea, flour chickpea, intact cell flour chickpea
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Gender: male and female * Age ≥ 18 years ≤ 65 years * Normal weight as classified by BMI 20-29.9 kg/m2 * Healthy, not diagnosed with any chronic diseases assessed as appropriate for inclusion, based on the pre-study screening. * Willingness and ability to understand, participate and to comply with the study requirements * Willingness and ability to give written informed consent
Exclusion criteria
* Has thyroid defects * Under hormone or steroids therapy * Is pregnant or lactating (female) * Had given birth within the past year (female) * Is taking drugs that could affect appetite or plasma glucose levels. * Is taking natural remedies that modulate appetite or plasma glucose levels. * Has excessive alcohol intake * Had blood donation within 12wks prior to start date * Psychiatric illness * Smokers * History of any disease with unknown outcome * Has diabetes * Has nut allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-prandial Glucose Concentrations | before the consumption of the test meal and then 15 min, 30, 60,90, 120, 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 |
| Post-prandial Blood Insulin Concentrations | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 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 |
| Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 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. |
| Energy Intake at a Meal Given in Excess | post consumption of the test meal at 120 minutes | 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. |
Participant flow
Pre-assignment details
this study was a randomized crossover study
Participants by arm
| Arm | Count |
|---|---|
| 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) | 2 |
| 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 | 3 |
| 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) | 2 |
| 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) | 3 |
| 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) | 2 |
| 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) | 3 |
| Total | 15 |
Baseline characteristics
| Characteristic | Experimental: Whole Chickpea First, Then Flour Chickpea, Then Intact Cell Chickpea | Experimental: Whole Chickpea First, Then Intact Cell Chickpea, Then Flour Chickpea | Experimental:Flour Chickpea First, Then Whole Chickpea, Then Intact Chickpea | Experimental: Flour Chickpea First, Intact Cell Chickpea, Whole Chickpea | Experimental: Intact Cell Chickpea First, Then Whole Chickpea, Then Flour Chickpea | Experimental: Intact Cell Chickpea First, Then Flour Chickpea, Then Whole Chickpea | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 15 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Chickpea | Post-prandial Blood Insulin Concentrations | 15 minutes | 16.8 uU/ml | Standard Deviation 9.6 |
| Whole Chickpea | Post-prandial Blood Insulin Concentrations | 90 minutes | 24.3 uU/ml | Standard Deviation 15.8 |
| Whole Chickpea | Post-prandial Blood Insulin Concentrations | 60 minutes | 29.1 uU/ml | Standard Deviation 20.4 |
| Whole Chickpea | Post-prandial Blood Insulin Concentrations | 0 minutes | 9.3 uU/ml | Standard Deviation 4.03 |
| Whole Chickpea | Post-prandial Blood Insulin Concentrations | 180 minutes | 14.9 uU/ml | Standard Deviation 8.5 |
| Whole Chickpea | Post-prandial Blood Insulin Concentrations | 120 minutes | 12.4 uU/ml | Standard Deviation 14.2 |
| Whole Chickpea | Post-prandial Blood Insulin Concentrations | 30 minutes | 29.3 uU/ml | Standard Deviation 12.5 |
| Flour Chickpea | Post-prandial Blood Insulin Concentrations | 60 minutes | 36.5 uU/ml | Standard Deviation 24.2 |
| Flour Chickpea | Post-prandial Blood Insulin Concentrations | 0 minutes | 10.3 uU/ml | Standard Deviation 5.4 |
| Flour Chickpea | Post-prandial Blood Insulin Concentrations | 15 minutes | 20 uU/ml | Standard Deviation 10.9 |
| Flour Chickpea | Post-prandial Blood Insulin Concentrations | 30 minutes | 37.5 uU/ml | Standard Deviation 17.3 |
| Flour Chickpea | Post-prandial Blood Insulin Concentrations | 90 minutes | 31.6 uU/ml | Standard Deviation 17.12 |
| Flour Chickpea | Post-prandial Blood Insulin Concentrations | 120 minutes | 34.1 uU/ml | Standard Deviation 24.5 |
| Flour Chickpea | Post-prandial Blood Insulin Concentrations | 180 minutes | 16.8 uU/ml | Standard Deviation 7.4 |
| Intact Cell Chickpea Hummus | Post-prandial Blood Insulin Concentrations | 90 minutes | 33.7 uU/ml | Standard Deviation 13.8 |
| Intact Cell Chickpea Hummus | Post-prandial Blood Insulin Concentrations | 15 minutes | 26.24 uU/ml | Standard Deviation 19.6 |
| Intact Cell Chickpea Hummus | Post-prandial Blood Insulin Concentrations | 180 minutes | 17.57 uU/ml | Standard Deviation 7.7 |
| Intact Cell Chickpea Hummus | Post-prandial Blood Insulin Concentrations | 120 minutes | 36.5 uU/ml | Standard Deviation 31.1 |
| Intact Cell Chickpea Hummus | Post-prandial Blood Insulin Concentrations | 60 minutes | 37.9 uU/ml | Standard Deviation 23.2 |
| Intact Cell Chickpea Hummus | Post-prandial Blood Insulin Concentrations | 30 minutes | 43.1 uU/ml | Standard Deviation 26 |
| Intact Cell Chickpea Hummus | Post-prandial Blood Insulin Concentrations | 0 minutes | 8.8 uU/ml | Standard Deviation 5.4 |
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Chickpea | Post-prandial Glucose Concentrations | Time point 30 | 5.1 mmol/l | Standard Deviation 0.57 |
| Whole Chickpea | Post-prandial Glucose Concentrations | Time point 90 | 5.07 mmol/l | Standard Deviation 0.73 |
| Whole Chickpea | Post-prandial Glucose Concentrations | Time point 15 | 4.9 mmol/l | Standard Deviation 0.53 |
| Whole Chickpea | Post-prandial Glucose Concentrations | Time point 120 | 5.18 mmol/l | Standard Deviation 0.56 |
| Whole Chickpea | Post-prandial Glucose Concentrations | Time point 60 | 5.08 mmol/l | Standard Deviation 0.78 |
| Whole Chickpea | Post-prandial Glucose Concentrations | Time point 180 | 5.14 mmol/l | Standard Deviation 0.46 |
| Whole Chickpea | Post-prandial Glucose Concentrations | time point 0 | 4.9 mmol/l | Standard Deviation 0.48 |
| Flour Chickpea | Post-prandial Glucose Concentrations | Time point 180 | 5.1 mmol/l | Standard Deviation 0.44 |
| Flour Chickpea | Post-prandial Glucose Concentrations | time point 0 | 4.8 mmol/l | Standard Deviation 0.31 |
| Flour Chickpea | Post-prandial Glucose Concentrations | Time point 15 | 5.01 mmol/l | Standard Deviation 0.38 |
| Flour Chickpea | Post-prandial Glucose Concentrations | Time point 30 | 5.4 mmol/l | Standard Deviation 0.53 |
| Flour Chickpea | Post-prandial Glucose Concentrations | Time point 60 | 4.9 mmol/l | Standard Deviation 0.87 |
| Flour Chickpea | Post-prandial Glucose Concentrations | Time point 90 | 4.8 mmol/l | Standard Deviation 0.6 |
| Flour Chickpea | Post-prandial Glucose Concentrations | Time point 120 | 4.9 mmol/l | Standard Deviation 0.4 |
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.
Time frame: post consumption of the test meal at 120 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whole Chickpea | Energy Intake at a Meal Given in Excess | 628.03 Kcal | Standard Deviation 321.7 |
| Flour Chickpea | Energy Intake at a Meal Given in Excess | 681.9 Kcal | Standard Deviation 326 |
| Intact Cell Chickpea Hummus | Energy Intake at a Meal Given in Excess | 724.7 Kcal | Standard Deviation 308.3 |
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
Time frame: before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 30 min | 343.7 pmol/L | Standard Deviation 166.9 |
| Whole Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 90 min | 509 pmol/L | Standard Deviation 199.5 |
| Whole Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 15 min | 102.6 pmol/L | Standard Deviation 34.47 |
| Whole Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 120 min | 466.48 pmol/L | Standard Deviation 171.32 |
| Whole Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 60 min | 508 pmol/L | Standard Deviation 186.8 |
| Whole Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 180 min | 378.1 pmol/L | Standard Deviation 153.9 |
| Whole Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | baseline 0 minutes | 43.02 pmol/L | Standard Deviation 23.07 |
| Flour Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 180 min | 440.7 pmol/L | Standard Deviation 199.4 |
| Flour Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | baseline 0 minutes | 47 pmol/L | Standard Deviation 20.6 |
| Flour Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 15 min | 181.3 pmol/L | Standard Deviation 97.3 |
| Flour Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 30 min | 516.2 pmol/L | Standard Deviation 217.9 |
| Flour Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 60 min | 651 pmol/L | Standard Deviation 220 |
| Flour Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 90 min | 601.9 pmol/L | Standard Deviation 199 |
| Flour Chickpea | Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP) | 120 min | 562.033 pmol/L | Standard Deviation 172.6 |
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.
Time frame: baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 15 min | 122.8 pmol/l | Standard Deviation 63.3 |
| Whole Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 90 min | 134.5 pmol/l | Standard Deviation 65.7 |
| Whole Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 60 min | 113.5 pmol/l | Standard Deviation 39.4 |
| Whole Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | baseline | 67.3 pmol/l | Standard Deviation 27.1 |
| Whole Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 180 min | 103.9 pmol/l | Standard Deviation 57.7 |
| Whole Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 120 min | 114.6 pmol/l | Standard Deviation 77 |
| Whole Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 30 min | 108.8 pmol/l | Standard Deviation 59.5 |
| Flour Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 60 min | 115.5 pmol/l | Standard Deviation 43.2 |
| Flour Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | baseline | 85.3 pmol/l | Standard Deviation 36.5 |
| Flour Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 15 min | 98.7 pmol/l | Standard Deviation 49.3 |
| Flour Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 30 min | 110.7 pmol/l | Standard Deviation 33 |
| Flour Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 90 min | 119 pmol/l | Standard Deviation 37.5 |
| Flour Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 120 min | 130.9 pmol/l | Standard Deviation 57.6 |
| Flour Chickpea | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 180 min | 109.2 pmol/l | Standard Deviation 53 |
| Intact Cell Chickpea Hummus | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 90 min | 120.3 pmol/l | Standard Deviation 66.5 |
| Intact Cell Chickpea Hummus | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 15 min | 91.7 pmol/l | Standard Deviation 34.2 |
| Intact Cell Chickpea Hummus | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 180 min | 92.9 pmol/l | Standard Deviation 49.4 |
| Intact Cell Chickpea Hummus | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 120 min | 108 pmol/l | Standard Deviation 46.4 |
| Intact Cell Chickpea Hummus | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 60 min | 128 pmol/l | Standard Deviation 42 |
| Intact Cell Chickpea Hummus | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | 30 min | 123.2 pmol/l | Standard Deviation 45.8 |
| Intact Cell Chickpea Hummus | Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1) | baseline | 80.8 pmol/l | Standard Deviation 31.2 |