NCT01055717

Brief Summary

This is a placebo-controlled, crossover study investigating the pharmacokinetic bioavailability of avenanthramides from avenanthramide-enriched oats and their in vivo metabolites in a cohort of healthy, older adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 27, 2013

Status Verified

May 1, 2013

Enrollment Period

9 months

First QC Date

January 25, 2010

Last Update Submit

May 23, 2013

Conditions

Healthy

Keywords

avenanthramideenrichedoatphytochemicalbioavailability

Outcome Measures

Primary Outcomes (1)

  • Levels of avenanthramides and their in vivo metabolites in blood, urine, and feces following the consumption of avenanthramide-enriched oats delivered in a baked muffin

    24 hours

Study Arms (2)

Placebo muffin made with no oats

PLACEBO COMPARATOR
Other: Avenanthramide-enriched oats

Test muffin made with AV-enriched oats

ACTIVE COMPARATOR
Other: Avenanthramide-enriched oats

Interventions

Avenanthramide-enriched oatsOTHER

Single dose, 24 hour pharmacokinetic trial

Placebo muffin made with no oatsTest muffin made with AV-enriched oats

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and postmenopausal women
  • BMI 18.5-29.9 kg/m2

You may not qualify if:

  • Cigarette smoking and/or nicotine replacement use
  • Use of cholesterol-lowering medications
  • Use of blood pressure-lowering medications
  • Use of any stomach acid-lowering medications
  • Cardiovascular (heart) disease
  • Gastrointestinal disease
  • Kidney disease
  • Endocrine disease: including diabetes, untreated thyroid disease
  • Rheumatoid arthritis
  • Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
  • Systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 95 mm Hg
  • Regular use of oral steroids
  • Regular daily intake of 2 or more alcoholic drinks
  • Illicit drug use
  • No fish oil supplements (including cod liver oil) for one month prior to study admission
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Gyrate Atrophy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesChoroid DiseasesUveal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jeffrey B Blumberg, PhD

    Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts Unversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

May 27, 2013

Record last verified: 2013-05

Locations

US(1)