NCT02840357

Brief Summary

The main purpose of this study is to determine the effect of consumption of purple wheat anthocyanin-rich products for eight weeks by human participants with an elevated level of chronic inflammation, on oxidative stress and inflammatory responses as measured by select plasma biomarkers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2016

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

July 19, 2016

Last Update Submit

March 29, 2018

Conditions

Healthy

Keywords

Chronic inflammationAdultsoverweightobese

Outcome Measures

Primary Outcomes (1)

  • Serum concentration of inflammatory biomarker (hs-CRP)

    Fasting (0 hours)

Secondary Outcomes (4)

  • Plasma concentration of lipids

    Fasting (0 hours)

  • Plasma concentration of inflammatory biomarkers

    Fasting (0 hours)

  • Plasma concentration of total antioxidant capacity

    Fasting (0 hours)

  • Plasma concentrations of anthocyanin metabolites and phenolic acids

    Fasting (0 hours)

Study Arms (2)

Treatment Group

EXPERIMENTAL

Purple Wheat Convenience Bars The treatment group will consume 4 servings /day of bran-enriched purple wheat convenience bars (40g/ serving)

Other: Purple Wheat Convenience Bars

Control Group

PLACEBO COMPARATOR

Control Wheat Convenience Bars The control group will consume 4 servings /day of bran-enriched ordinary wheat convenience basr (40g/ serving)

Other: Control Wheat Convenience Bars

Interventions

Purple Wheat Convenience BarsOTHER

Whole grain convenience bars manufactured with purple wheat

Treatment Group
Control Wheat Convenience BarsOTHER

Whole grain convenience bars manufactured with ordinary wheat

Control Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 25 kg/m2 and/or Waist circumference ≥102 cm (men) and ≥88 cm (women)
  • hs-CRP: ≥ 1.0 mg/L at time of screening
  • Stable (\>3 months) and consistent use of all prescribed medications and/or supplements
  • Non- to moderate alcohol consumer (i.e. less than 5 drinks per sitting and no more than 14 per week)
  • Not taking any antibiotics within the last 3 months, or planning to take antibiotics within the next 6 months

You may not qualify if:

  • Pregnant or breastfeeding females
  • Lifetime history of any acute medical event, including but not limited to, heart attack or stroke
  • Occasional or intermittent smoker (includes but not limited to tobacco and cannabis)
  • Consistent smoker of \<1 year
  • Recent diagnosis (within 6 months) of a serious medical condition, including but not limited to, cancer, diabetes, heart disease or hepatitis
  • Recent history (within 6 months) of a clinically significant psychiatric disorder, other than mild depression
  • Any disorder of the gastrointestinal system or food intolerances, including but not limited to, inflammatory bowel disease or Celiac disease
  • Any food allergies or any life-threatening allergies, food or otherwise
  • Regular recreational drug use of more than once per week, including but not limited to cannabis, magic mushrooms, ecstasy etc
  • Difficulty providing blood samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutraceutical Research Unit, University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Amanda Wright, Ph.D

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 21, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

April 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

Through peer reviewed publications.

Locations

CA(1)