Healthy
Conditions
Keywords
Cereals, Alkylresorcinols, Betaine, Phenolics, Plasma and urine cereal phytochemicals
Brief summary
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.
Detailed description
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.
Interventions
OTHEREsterase wholegrain wheat flour
A treated cereal flour mixed with milk.
OTHERWholegrain wheat flour
A treated cereal flour mixed with milk.
OTHERLiquid whole grain wheat flour
A treated cereal flour mixed with milk.
OTHERWholegrain barley flour
A treated cereal flour mixed with milk.
OTHERLiquid wholegrain barley flour
A treated cereal flour mixed with milk.
OTHERRefined wheat flour
A treated cereal flour mixed with milk.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * Normal-overweight (BMI 19-28 kg/m2) * Non-smokers
Exclusion criteria
* Regular consumers of wholegrain cereals * Allergy to cereal or milk products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Alkylresorcinol Compounds | From 0 to 48 h post dose. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma and Urinary Betaine | From 0 to 48 hours post dose | — |
| Phenolic Acids | 0-48 h post dose | Phenolic acids in plasma and urine |
Countries
Switzerland
Participant flow
Recruitment details
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
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 1st Intervention (1 Day) | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Customized < 18 years | 0 participants |
| Age, Customized > 55 years | 0 participants |
| Age, Customized between 18 and 55 years | 14 participants |
| Region of Enrollment Switzerland | 14 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 |
Outcome results
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.
Time frame: From 0 to 48 h post dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esterase Whole Grain Wheat Flour | Plasma Alkylresorcinol Compounds | 19357 nmol/L*h | Standard Deviation 7509 |
| Refined Wheat Flour | Plasma Alkylresorcinol Compounds | 1548 nmol/L*h | Standard Deviation 698 |
| Liquid Whole Grain Wheat Flour | Plasma Alkylresorcinol Compounds | 17307 nmol/L*h | Standard Deviation 5914 |
| Liquid Wholegrain Barley Flour | Plasma Alkylresorcinol Compounds | 5385 nmol/L*h | Standard Deviation 2642 |
| Wholegrain Wheat Flour | Plasma Alkylresorcinol Compounds | 17139 nmol/L*h | Standard Deviation 6386 |
| Wholegrain Barley Flour | Plasma Alkylresorcinol Compounds | 5634 nmol/L*h | Standard Deviation 2478 |
Secondary
Phenolic Acids
Phenolic acids in plasma and urine
Time frame: 0-48 h post dose
Secondary
Plasma and Urinary Betaine
Time frame: From 0 to 48 hours post dose