HealthyNCT01287403

Response of Alkylresorcinols to Different Cereals

A study testing Refined wheat flour, Esterase wholegrain wheat flour and Wholegrain wheat flour in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Refined wheat flour, Esterase wholegrain wheat flour and Wholegrain wheat flour
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteSwitzerland
Study dates: Jan 2011to Dec 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy
Normal-overweight (BMI 19-28 kg/m2)
Non-smokers

Who cannot join

Regular consumers of wholegrain cereals
Allergy to cereal or milk products

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

NESTEC / Clinical Development Unit / Metabolic Unit
Lausanne, Canton of Vaud, 1000

Other trials in Switzerland

About this study

Official title: Response of Alkylresorcinols and Other Biomarkers to Different Cereals

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.

Read the 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.

Conditions: Healthy
Being tested: Refined wheat flour, Esterase wholegrain wheat flour, Wholegrain wheat flour, Liquid whole grain wheat flour, Wholegrain barley flour
Keywords: Cereals, Alkylresorcinols, Betaine, Phenolics, Plasma and urine cereal phytochemicals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Refined wheat flourOther
A treated cereal flour mixed with milk.
Esterase wholegrain wheat flourOther
A treated cereal flour mixed with milk.
Wholegrain wheat flourOther
A treated cereal flour mixed with milk.
Liquid whole grain wheat flourOther
A treated cereal flour mixed with milk.
Wholegrain barley flourOther
A treated cereal flour mixed with milk.
Liquid wholegrain barley flourOther
A treated cereal flour mixed with milk.

Study groups in NCT01287403
Study group	Role	What they receive
Refined wheat flour	Placebo comparator	A negative control flour to serve as a reference. Receives: Other: Esterase wholegrain wheat flour; Other: Wholegrain wheat flour; Other: Liquid whole grain wheat flour; Other: Wholegrain barley flour; Other: Liquid wholegrain barley flour
Esterase wholegrain wheat flour	Active comparator	Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids) Receives: Other: Refined wheat flour; Other: Wholegrain wheat flour; Other: Liquid whole grain wheat flour; Other: Wholegrain barley flour; Other: Liquid wholegrain barley flour
Wholegrain wheat flour	Experimental	Flour with unknown response Receives: Other: Refined wheat flour; Other: Esterase wholegrain wheat flour; Other: Liquid whole grain wheat flour; Other: Wholegrain barley flour; Other: Liquid wholegrain barley flour
Liquid whole grain wheat flour	Experimental	Test flour with unknown response. Receives: Other: Refined wheat flour; Other: Esterase wholegrain wheat flour; Other: Wholegrain wheat flour; Other: Wholegrain barley flour; Other: Liquid wholegrain barley flour
Wholegrain barley flour	Experimental	Test flour with unknown response. Receives: Other: Refined wheat flour; Other: Esterase wholegrain wheat flour; Other: Wholegrain wheat flour; Other: Liquid whole grain wheat flour; Other: Liquid wholegrain barley flour
Liquid wholegrain barley flour	Experimental	Test flour with unknown response. Receives: Other: Refined wheat flour; Other: Esterase wholegrain wheat flour; Other: Wholegrain wheat flour; Other: Liquid whole grain wheat flour; Other: Wholegrain barley flour

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From 0 to 48 h post dose.

Secondary outcomes (2)

Plasma and Urinary Betaine
Measured: From 0 to 48 hours post dose
Phenolic Acids
Phenolic acids in plasma and urine
Measured: 0-48 h post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Dec 2012

First posted1 Feb 2011 (estimated)
Study startJan 2011
Primary completionAug 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01287403
Sponsor's protocol ID: 10.14 MET
Status last verified: Aug 2018
First submitted: 30 Jan 2011
Last updated: 31 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Response of Alkylresorcinols and Other Biomarkers to Different Cereals
ClinicalTrials.gov ID: NCT01287403
Acronym / sponsor ID: 10.14 MET
Conditions: Healthy
Keywords: Cereals, Alkylresorcinols, Betaine, Phenolics, Plasma and urine cereal phytochemicals
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Aug 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 1 Feb 2011 (estimated)
Results: Posted 14 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Refined wheat flour	Placebo comparator	Other: Esterase wholegrain wheat flour, Other: Wholegrain wheat flour, Other: Liquid whole grain wheat flour, Other: Wholegrain barley flour, Other: Liquid wholegrain barley flourA negative control flour to serve as a reference.
Esterase wholegrain wheat flour	Active comparator	Other: Refined wheat flour, Other: Wholegrain wheat flour, Other: Liquid whole grain wheat flour, Other: Wholegrain barley flour, Other: Liquid wholegrain barley flourWholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)
Wholegrain wheat flour	Experimental	Other: Refined wheat flour, Other: Esterase wholegrain wheat flour, Other: Liquid whole grain wheat flour, Other: Wholegrain barley flour, Other: Liquid wholegrain barley flourFlour with unknown response
Liquid whole grain wheat flour	Experimental	Other: Refined wheat flour, Other: Esterase wholegrain wheat flour, Other: Wholegrain wheat flour, Other: Wholegrain barley flour, Other: Liquid wholegrain barley flourTest flour with unknown response.
Wholegrain barley flour	Experimental	Other: Refined wheat flour, Other: Esterase wholegrain wheat flour, Other: Wholegrain wheat flour, Other: Liquid whole grain wheat flour, Other: Liquid wholegrain barley flourTest flour with unknown response.
Liquid wholegrain barley flour	Experimental	Other: Refined wheat flour, Other: Esterase wholegrain wheat flour, Other: Wholegrain wheat flour, Other: Liquid whole grain wheat flour, Other: Wholegrain barley flourTest flour with unknown response.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy
Normal-overweight (BMI 19-28 kg/m2)
Non-smokers

Key exclusion criteria (2 listed)

Regular consumers of wholegrain cereals
Allergy to cereal or milk products

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Refined wheat flourA treated cereal flour mixed with milk.	Other	Esterase wholegrain wheat flour, Liquid whole grain wheat flour, Liquid wholegrain barley flour, Wholegrain barley flour, Wholegrain wheat flour
Esterase wholegrain wheat flourA treated cereal flour mixed with milk.	Other	Liquid whole grain wheat flour, Liquid wholegrain barley flour, Refined wheat flour, Wholegrain barley flour, Wholegrain wheat flour
Wholegrain wheat flourA treated cereal flour mixed with milk.	Other	Esterase wholegrain wheat flour, Liquid whole grain wheat flour, Liquid wholegrain barley flour, Refined wheat flour, Wholegrain barley flour
Liquid whole grain wheat flourA treated cereal flour mixed with milk.	Other	Esterase wholegrain wheat flour, Liquid wholegrain barley flour, Refined wheat flour, Wholegrain barley flour, Wholegrain wheat flour
Wholegrain barley flourA treated cereal flour mixed with milk.	Other	Esterase wholegrain wheat flour, Liquid whole grain wheat flour, Liquid wholegrain barley flour, Refined wheat flour, Wholegrain wheat flour
Liquid wholegrain barley flourA treated cereal flour mixed with milk.	Other	Esterase wholegrain wheat flour, Liquid whole grain wheat flour, Refined wheat flour, Wholegrain barley flour, Wholegrain wheat flour

Primary outcome

Plasma Alkylresorcinol Compounds
Time frame: 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.

2 secondary outcomes

Plasma and Urinary Betaine
Time frame: From 0 to 48 hours post dose
Phenolic Acids
Time frame: 0-48 h post dose

Results and safety

Results posted to the registry on 14 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Six Products (Flours) Assigned Randomly (Cross Over)	14	14

Primary outcome: Plasma Alkylresorcinol Compounds

Time frame: From 0 to 48 h post dose.. Mean (Standard Deviation). Unit: nmol/L*h

Measure	Esterase Whole Grain Wheat Flour n = 13	Refined Wheat Flour n = 13	Liquid Whole Grain Wheat Flour n = 13	Liquid Wholegrain Barley Flour n = 13	Wholegrain Wheat Flour n = 13	Wholegrain Barley Flour n = 13
Value	19357 (7509)	1548 (698)	17307 (5914)	5385 (2642)	17139 (6386)	5634 (2478)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: This adverse event occurred during the 1st intervention. The subject did not wish to go on with the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Refined Wheat Flour	0 of 14 (0%)	1 of 14 (7.1%)	Not reported
Esterase Wholegrain Wheat Flour	0 of 14 (0%)	0 of 14 (0%)	Not reported
Liquid Whole Grain Wheat Flour	0 of 14 (0%)	0 of 14 (0%)	Not reported
Liquid Wholegrain Barley Flour	0 of 14 (0%)	0 of 14 (0%)	Not reported
Wholegrain Wheat Flour	0 of 14 (0%)	0 of 14 (0%)	Not reported
Wholegrain Barley Flour	0 of 14 (0%)	0 of 14 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alastair B Ross, PhD study director

Société des Produits Nestlé (SPN)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Refined wheat flour, Esterase wholegrain wheat flour and Wholegrain wheat flour in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Alkylresorcinol Compounds (time frame: From 0 to 48 h post dose.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01287403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.