Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status
NCT ID: NCT03213288
Last Updated: 2019-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2017-09-25
2018-09-30
Brief Summary
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Detailed Description
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In a randomized 3 phase crossover study we aim to recruit 50 participants (men and women) aged 45 years or more with a higher than optimal blood cholesterol level to consume capsules containing (i) 320 mg anthocyanins derived from bilberry fruit (delphinidin type), (ii) 320 mg anthocyanins derived from black rice (cyanidin type) and (iii) a placebo control. Each treatment will be ingested for 28 days with a wash-out period of 4 weeks in-between. Blood samples will be collected at the start and end of each 28-day treatment period to assess lipid status. In a subset of participants we will also investigate the relationship between bilberry and black rice anthocyanin ingestion on RNA expression profiles that are known to be involved in atherosclerosis, non-alcoholic fatty liver disease and reverse cholesterol transport as well as faecal excretion of bile acids and lipids.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Delphinidin type anthocyanins
Bilberry extract
Delphinidin type anthocyanins
Bilberry extract containing Delphinidin type anthocyanins
Cyanidin type anthocyanins
Black rice extract
Cyanidin type anthocyanins
Black rice extract containing Cyanidin type anthocyanins
Placebo
No anthocyanins
Placebo
No anthocyanins
Interventions
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Delphinidin type anthocyanins
Bilberry extract containing Delphinidin type anthocyanins
Cyanidin type anthocyanins
Black rice extract containing Cyanidin type anthocyanins
Placebo
No anthocyanins
Eligibility Criteria
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Inclusion Criteria
* Total cholesterol ≥ 5.0 mmol/L
Exclusion Criteria
* Medical conditions that are judged to affect the primary outcome measure for this study or which may compromise the well-being of the participant e.g. diabetes.
* Prescribed and non-prescribed medications that may affect the primary outcome measure for this study e.g. lipid lowering therapy
* Dietary supplements judged to affect the study data unless the participant is willing to discontinue them for 4 weeks preceding the start of the study and for the duration of the study
* Use foods for lowering cholesterol e.g. benecol, flora proactive
* Regular/recent use of colonic irrigation or other bowel cleansing techniques.
* Intend to change the normal use of pre or probiotics during the study (only applies to those collecting faecal samples)
* Bowel movements ≤ 3 times per week (only applies to those collecting faecal samples)
* Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
* Parallel participation in another research project which involves dietary intervention
* Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 ml.
* Has donated or intends to donate blood within 16 weeks prior to or during the study period.
* Any person related to or living with any member of the study team
* Lack of capacity to provide written informed consent
* Are pregnant or have been pregnant within the last 12 months
45 Years
ALL
Yes
Sponsors
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Quadram Institute Bioscience
OTHER
Responsible Party
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Principal Investigators
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Paul Kroon
Role: PRINCIPAL_INVESTIGATOR
Quadram Institute Bioscience
Locations
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Quadram Institute Bioscience
Norwich, , United Kingdom
Countries
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Other Identifiers
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IFR01/2017
Identifier Type: -
Identifier Source: org_study_id