HealthyNCT02840357
Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.
A study testing Purple Wheat Convenience Bars in people with Healthy, run by University of Guelph at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Purple Wheat Convenience Bars
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Human Nutraceutical Research Unit, University of Guelph
Guelph, Ontario, N1G 2W1
About this study
Official title: The Purple Wheat Intervention Study: Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.
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.
Read the detailed description
This study will investigate the effect of daily consumption of purple wheat bran-enriched wholegrain convenience bars, for 8 weeks on inflammation and oxidative stress biomarkers and plasma antioxidant capacity. This study is a randomized, parallel arm study with 20 men and 20 women who will adhere to a low anthocyanin and low phenolic aid diet for the duration of the study. The participants will be randomly divided into two groups, using stratification for matching sex and screening hs-CRP level to be equally distributed in each group, and assigned to either the treatment group or control group. Both group will have a 10 day diet run-in period where consumption of foods rich in anthocyanins and phenolic acids will be limited. Both groups will consume 4 servings of wheat products per day for 8 weeks and will replace 4 grain servings from their typical daily intake with the study treatment products. Fasting blood samples will be collected during three study visits, including baseline, for the analysis of inflammatory and oxidative stress biomarkers and plasma antioxidant capacity. The plasma metabolites of anthocyanins and phenolic acids will also be determined.
- Conditions
- Healthy
- Being tested
- Purple Wheat Convenience Bars, Control Wheat Convenience Bars
- Keywords
- Chronic inflammation, Adults, overweight, obese
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purple Wheat Convenience BarsOther
Whole grain convenience bars manufactured with purple wheat
Control Wheat Convenience BarsOther
Whole grain convenience bars manufactured with ordinary wheat
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Purple Wheat Convenience Bars The treatment group will consume 4 servings /day of bran-enriched purple wheat convenience bars (40g/ serving) Receives: 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) Receives: Other: Control Wheat Convenience Bars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of inflammatory biomarker (hs-CRP)
Measured: Fasting (0 hours)
Secondary outcomes (4)
Plasma concentration of lipids
Measured: Fasting (0 hours)
Plasma concentration of inflammatory biomarkers
Measured: Fasting (0 hours)
Plasma concentration of total antioxidant capacity
Measured: Fasting (0 hours)
Plasma concentrations of anthocyanin metabolites and phenolic acids
Measured: Fasting (0 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion1 Jul 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Wright, Ph.D., University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840357
- Sponsor's protocol ID
- PWIS2
- Status last verified
- Mar 2018
- First submitted
- 19 Jul 2016
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Through peer reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Purple Wheat Intervention Study: Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.
- ClinicalTrials.gov ID
- NCT02840357
- Acronym / sponsor ID
- PWIS2
- Conditions
- Healthy
- Keywords
- Chronic inflammation, Adults, overweight, obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will investigate the effect of daily consumption of purple wheat bran-enriched wholegrain convenience bars, for 8 weeks on inflammation and oxidative stress biomarkers and plasma antioxidant capacity. This study is a randomized, parallel arm study with 20 men and 20 women who will adhere to a low anthocyanin and low phenolic aid diet for the duration of the study. The participants will be randomly divided into two groups, using stratification for matching sex and screening hs-CRP level to be equally distributed in each group, and assigned to either the treatment group or control group. Both group will have a 10 day diet run-in period where consumption of foods rich in anthocyanins and phenolic acids will be limited. Both groups will consume 4 servings of wheat products per day for 8 weeks and will replace 4 grain servings from their typical daily intake with the study treatment products. Fasting blood samples will be collected during three study visits, including baseline, for the analysis of inflammatory and oxidative stress biomarkers and plasma antioxidant capacity. The plasma metabolites of anthocyanins and phenolic acids will also be determined.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Purple Wheat Convenience BarsPurple Wheat Convenience Bars The treatment group will consume 4 servings /day of bran-enriched purple wheat convenience bars (40g/ serving) |
| Control Group | Placebo comparator | Other: Control Wheat Convenience BarsControl Wheat Convenience Bars The control group will consume 4 servings /day of bran-enriched ordinary wheat convenience basr (40g/ serving) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Purple Wheat Convenience BarsWhole grain convenience bars manufactured with purple wheat | Other | Treatment Group |
| Control Wheat Convenience BarsWhole grain convenience bars manufactured with ordinary wheat | Other | Control Group |
Primary outcome
Serum concentration of inflammatory biomarker (hs-CRP)
Time frame: Fasting (0 hours)
4 secondary outcomes
Plasma concentration of lipids
Time frame: Fasting (0 hours)
Plasma concentration of inflammatory biomarkers
Time frame: Fasting (0 hours)
Plasma concentration of total antioxidant capacity
Time frame: Fasting (0 hours)
Plasma concentrations of anthocyanin metabolites and phenolic acids
Time frame: Fasting (0 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Individual participant dataSharing planned: Yes. Through peer reviewed publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purple Wheat Convenience Bars in people with Healthy, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of inflammatory biomarker (hs-CRP) (time frame: Fasting (0 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.