Response of Alkylresorcinols to Different Cereals

Healthy Clinical Trial

Official title:

Response of Alkylresorcinols and Other Biomarkers to Different Cereals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287403
• Other study ID #: 10.14 MET
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Switzerland	NESTEC / Clinical Development Unit / Metabolic Unit	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	From 0 to 48 h post dose.
Secondary	Plasma and Urinary Betaine		From 0 to 48 hours post dose
Secondary	Phenolic Acids	Phenolic acids in plasma and urine	0-48 h post dose