Response of Alkylresorcinols to Different Cereals

NCT01287403 | Completed Results

• 1 other identifier: 10.14 MET
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Cereals; Alkylresorcinols; Betaine; Phenolics; Plasma and urine cereal phytochemicals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Plasma and Urinary Betaine

  From 0 to 48 hours post dose

• Phenolic Acids

  0-48 h post dose

Study Arms (6)

Refined wheat flour

PLACEBO COMPARATOR

A negative control flour to serve as a reference.

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)

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

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.

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.

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.

Other: Refined wheat flour; Other: Esterase wholegrain wheat flour; Other: Wholegrain wheat flour; Other: Liquid whole grain wheat flour; Other: Wholegrain barley flour

Interventions

Refined wheat flour OTHER

A treated cereal flour mixed with milk.

Esterase wholegrain wheat flour; Liquid whole grain wheat flour; Liquid wholegrain barley flour; Wholegrain barley flour; Wholegrain wheat flour

Esterase wholegrain wheat flour OTHER

A treated cereal flour mixed with milk.

Liquid whole grain wheat flour; Liquid wholegrain barley flour; Refined wheat flour; Wholegrain barley flour; Wholegrain wheat flour

Wholegrain wheat flour OTHER

A treated cereal flour mixed with milk.

Esterase wholegrain wheat flour; Liquid whole grain wheat flour; Liquid wholegrain barley flour; Refined wheat flour; Wholegrain barley flour

Liquid whole grain wheat flour OTHER

A treated cereal flour mixed with milk.

Esterase wholegrain wheat flour; Liquid wholegrain barley flour; Refined wheat flour; Wholegrain barley flour; Wholegrain wheat flour

Wholegrain barley flour OTHER

A treated cereal flour mixed with milk.

Esterase wholegrain wheat flour; Liquid whole grain wheat flour; Liquid wholegrain barley flour; Refined wheat flour; Wholegrain wheat flour

Liquid wholegrain barley flour OTHER

A treated cereal flour mixed with milk.

Esterase wholegrain wheat flour; Liquid whole grain wheat flour; Refined wheat flour; Wholegrain barley flour; Wholegrain wheat flour

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Regular consumers of wholegrain cereals
• Allergy to cereal or milk products

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

NESTEC / Clinical Development Unit / Metabolic Unit

Lausanne, Canton of Vaud, 1000, Switzerland

Location

Results Point of Contact

• Title: Dr Maurice Beaumont, MD, PhD
• Organization: Clinical Development Unit / Metabolic Unit

maurice.beaumont@rdls.nestle.com

+41217858054

Study Officials

• Alastair B Ross, PhD

  Société des Produits Nestlé (SPN)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 30, 2011
• First Posted: February 1, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 31, 2018
• Results First Posted: August 14, 2013

Record last verified: 2018-08

Locations

CH (1)