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Cereal grains contain a wide variety of different phytochemicals which may play different roles in physiology. Their response in plasma and urine after a meal is poorly defined for most cereals. This study will investigate the plasma response and urinary excretion of cereal compounds after eating 6 different types of cereal preparation, with a focus on alkylresorcinols.
This was a cross-over, randomized, double blind study with 6 arms (flours of different composition). Thirteen subjects completed the trial, where 100 g of each flour, mixed with 300 mL milk, was fed to all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refined wheat flour | Placebo Comparator | A negative control flour to serve as a reference. |
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| Esterase wholegrain wheat flour | Active Comparator | Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids) |
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| Wholegrain wheat flour | Experimental | Flour with unknown response |
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| Liquid whole grain wheat flour | Experimental | Test flour with unknown response. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Refined wheat flour | Other | A treated cereal flour mixed with milk. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Alkylresorcinol Compounds | Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake. | From 0 to 48 h post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and Urinary Betaine | From 0 to 48 hours post dose | |
| Phenolic Acids | Phenolic acids in plasma and urine | 0-48 h post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alastair B Ross, PhD | Société des Produits Nestlé (SPN) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NESTEC / Clinical Development Unit / Metabolic Unit | Lausanne | Canton of Vaud | 1000 | Switzerland |
Thirteen subjects completed the trial, where 100 g of each flour, mixed with 300 mL milk, was fed to all subjects.
Subjects avoided foods containing whole grains for one week prior, and 36 h before the start of each treatment, to avoid all phenolic-rich foods (e.g. coffee, tea, chocolate, most fruits and vegetables).
14 healthy subjects were recruited within the staff of the Nestle Research Center. After being informed, by written and orally, on the aims, methods, risk/benefit ratio for the study, they signed an informed consent form and underwent a medical visit screening as per protocol
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| ID | Title | Description |
|---|---|---|
| FG000 | Six Products (Flours) Assigned Randomly (Cross Over) | In a crossover design, all subjects were administered the 6 following products in a randomized order: Esterase wholegrain wheat flour: a cereal flour treated with esterases to release phenolics (positive control for phenolic acids). Refined wheat flour: a treated cereal flour mixed with milk (negative control). Liquid whole grain wheat flour: a treated cereal flour mixed with milk. Liquid wholegrain barley flour: a treated cereal flour mixed with milk. Wholegrain wheat flour: a treated cereal flour mixed with milk. Wholegrain barley flour: a treated cereal flour mixed with milk. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Diet Restriction (7 Days) |
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| 1st Intervention (1 Day) |
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| Washout 7 Days |
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| 2nd Intervention (1 Day) |
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| Washout (7 Days) |
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| 3rd Intervention (1 Day) |
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| Washout (7 Days) |
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| 4th Intervention (1 Day) |
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| Washout (7 Days) |
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| 5th Intervention (1 Day) |
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| Washout (7 Days) |
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| 6th and Last Intervention (1 Day) |
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All subjects were recruited within the staff of the Nestlé Research Center between February and June 2011.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive either esterase wholegrain wheat flour first or liquid wholegrain wheat flour first or liquid wholegrain barley flour first or refined wheat flour first or wholegrain wheat flour first or wholegrain barley flour first |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Plasma Alkylresorcinol Compounds | Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake. | Posted | Mean | Standard Deviation | nmol/L*h | From 0 to 48 h post dose. |
|
This adverse event occurred during the 1st intervention. The subject did not wish to go on with the study.
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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 | Refined Wheat Flour | A treated cereal flour mixed with milk (negative control). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Vomiting | Non-systematic Assessment | The subject complain of nausea in the hour following the product intake and vomitted 8 hours later. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Maurice Beaumont, MD, PhD | Clinical Development Unit / Metabolic Unit | +41217858054 | maurice.beaumont@rdls.nestle.com |
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| Wholegrain barley flour |
| Experimental |
Test flour with unknown response. |
|
| Liquid wholegrain barley flour | Experimental | Test flour with unknown response. |
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| Esterase wholegrain wheat flour | Other | A treated cereal flour mixed with milk. |
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| Wholegrain wheat flour | Other | A treated cereal flour mixed with milk. |
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| Liquid whole grain wheat flour | Other | A treated cereal flour mixed with milk. |
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| Wholegrain barley flour | Other | A treated cereal flour mixed with milk. |
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| Liquid wholegrain barley flour | Other | A treated cereal flour mixed with milk. |
|
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| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Liquid Whole Grain Wheat Flour |
A treated cereal flour mixed with milk. |
| OG003 | Liquid Wholegrain Barley Flour | A treated cereal flour mixed with milk. |
| OG004 | Wholegrain Wheat Flour | A treated cereal flour mixed with milk. |
| OG005 | Wholegrain Barley Flour | A treated cereal flour mixed with milk. |
|
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| Secondary | Plasma and Urinary Betaine | Not Posted | From 0 to 48 hours post dose | Participants |
| Secondary | Phenolic Acids | Phenolic acids in plasma and urine | Not Posted | 0-48 h post dose | Participants |
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Esterase Wholegrain Wheat Flour | A cereal flour treated with esterases to release phenolics (positive control for phenolic acids) | 0 | 14 | 0 | 14 |
| EG002 | Liquid Whole Grain Wheat Flour | A treated cereal flour mixed with milk. | 0 | 14 | 0 | 14 |
| EG003 | Liquid Wholegrain Barley Flour | A treated cereal flour mixed with milk. | 0 | 14 | 0 | 14 |
| EG004 | Wholegrain Wheat Flour | A treated cereal flour mixed with milk. | 0 | 14 | 0 | 14 |
| EG005 | Wholegrain Barley Flour | A treated cereal flour mixed with milk. | 0 | 14 | 0 | 14 |
|
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