NCT01303562

Brief Summary

The goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h) bioavailability and pharmacokinetics of the major phytochemicals found whole barley and oats, as well as their effects on selected measures of antioxidation, inflammation, insulin sensitivity/glucose regulation, and vascular remodeling following challenge by an oral glucose tolerance test (OGTT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable healthy

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

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

May 27, 2013

Status Verified

May 1, 2013

Enrollment Period

7 months

First QC Date

November 16, 2010

Last Update Submit

May 23, 2013

Conditions

Healthy

Keywords

oatbarleywhole grainbioavailabilityphytochemical

Outcome Measures

Primary Outcomes (1)

  • Levels of phytochemicals and their in vivo metabolites in blood

    Levels of phytochemicals and their in vivo metabolites in blood, urine, and feces following the consumption of whole grains delivered in a baked muffin

    24 hours

Study Arms (3)

Placebo muffin made with no whole grains

PLACEBO COMPARATOR
Other: Whole grain oats and barley

Test muffin made with whole oats

ACTIVE COMPARATOR
Other: Whole grain oats and barley

Test muffin made with whole barley

ACTIVE COMPARATOR
Other: Whole grain oats and barley

Interventions

Whole grain oats and barleyOTHER

One time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention

Placebo muffin made with no whole grainsTest muffin made with whole barleyTest muffin made with whole oats

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and postmenopausal women
  • BMI 27-35.9 kg/m2

You may not qualify if:

  • Cigarette smoking and/or nicotine replacement use
  • Individuals taking estrogen
  • Use of cholesterol-lowering medications
  • Use of blood pressure-lowering medications
  • Regular use of any stomach acid-lowering medications or laxatives (including fiber supplements)
  • 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 mmHg and/or diastolic blood pressure \> 95 mmHg
  • Regular use of oral steroids
  • Regular daily intake of ≥ 2 alcoholic drinks
  • Infrequent or excessive number of regular bowel movements
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Clinical and Translational Research Center

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

    Tufts Medical Center

    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

November 16, 2010

First Posted

February 24, 2011

Study Start

September 1, 2010

Primary Completion

April 1, 2011

Study Completion

February 1, 2013

Last Updated

May 27, 2013

Record last verified: 2013-05

Locations

US(1)