Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-01-24 @ 2:54 PM
Study NCT ID:
NCT02840357
Status:
COMPLETED
Last Update Posted:
2018-04-02
First Post:
2016-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-29', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum concentration of inflammatory biomarker (hs-CRP)', 'timeFrame': 'Fasting (0 hours)'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration of lipids', 'timeFrame': 'Fasting (0 hours)'}, {'measure': 'Plasma concentration of inflammatory biomarkers', 'timeFrame': 'Fasting (0 hours)'}, {'measure': 'Plasma concentration of total antioxidant capacity', 'timeFrame': 'Fasting (0 hours)'}, {'measure': 'Plasma concentrations of anthocyanin metabolites and phenolic acids', 'timeFrame': 'Fasting (0 hours)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic inflammation', 'Adults', 'overweight', 'obese'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥ 25 kg/m2 and/or Waist circumference ≥102 cm (men) and ≥88 cm (women)\n* hs-CRP: ≥ 1.0 mg/L at time of screening\n* Stable (\\>3 months) and consistent use of all prescribed medications and/or supplements\n* Non- to moderate alcohol consumer (i.e. less than 5 drinks per sitting and no more than 14 per week)\n* Not taking any antibiotics within the last 3 months, or planning to take antibiotics within the next 6 months\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding females\n* Lifetime history of any acute medical event, including but not limited to, heart attack or stroke\n* Occasional or intermittent smoker (includes but not limited to tobacco and cannabis)\n* Consistent smoker of \\<1 year\n* Recent diagnosis (within 6 months) of a serious medical condition, including but not limited to, cancer, diabetes, heart disease or hepatitis\n* Recent history (within 6 months) of a clinically significant psychiatric disorder, other than mild depression\n* Any disorder of the gastrointestinal system or food intolerances, including but not limited to, inflammatory bowel disease or Celiac disease\n* Any food allergies or any life-threatening allergies, food or otherwise\n* Regular recreational drug use of more than once per week, including but not limited to cannabis, magic mushrooms, ecstasy etc\n* Difficulty providing blood samples'}, 'identificationModule': {'nctId': 'NCT02840357', 'briefTitle': 'Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.', 'organization': {'class': 'OTHER', 'fullName': 'University of Guelph'}, 'officialTitle': 'The Purple Wheat Intervention Study: Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.', 'orgStudyIdInfo': {'id': 'PWIS2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Purple Wheat Convenience Bars The treatment group will consume 4 servings /day of bran-enriched purple wheat convenience bars (40g/ serving)', 'interventionNames': ['Other: Purple Wheat Convenience Bars']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Control Wheat Convenience Bars The control group will consume 4 servings /day of bran-enriched ordinary wheat convenience basr (40g/ serving)', 'interventionNames': ['Other: Control Wheat Convenience Bars']}], 'interventions': [{'name': 'Purple Wheat Convenience Bars', 'type': 'OTHER', 'description': 'Whole grain convenience bars manufactured with purple wheat', 'armGroupLabels': ['Treatment Group']}, {'name': 'Control Wheat Convenience Bars', 'type': 'OTHER', 'description': 'Whole grain convenience bars manufactured with ordinary wheat', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N1G 2W1', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Human Nutraceutical Research Unit, University of Guelph', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Through peer reviewed publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guelph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Amanda Wright, Ph.D', 'investigatorFullName': 'Amanda Wright, Ph.D.', 'investigatorAffiliation': 'University of Guelph'}}}}