- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03213288
Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status
The Effects of Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status in Adults
Study Overview
Status
Conditions
Detailed Description
Human intervention trials with anthocyanin-rich berry fruits/extracts such as whole strawberries, elderberry juice and whortleberry extracts, and purified anthocyanins from a mixture of blackcurrant and bilberry have been shown to beneficially alter biological markers for CVD risk, with beneficial effects on lipid profiles common across these studies.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Norwich, United Kingdom, NR4 7UA
- Quadram Institute Bioscience
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women ≥ 45 years of age
- Total cholesterol ≥ 5.0 mmol/L
Exclusion Criteria:
- Smokers (or stopped smoking for less than 3 months)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Delphinidin type anthocyanins
Bilberry extract
|
Bilberry extract containing Delphinidin type anthocyanins
|
Active Comparator: Cyanidin type anthocyanins
Black rice extract
|
Black rice extract containing Cyanidin type anthocyanins
|
Placebo Comparator: Placebo
No anthocyanins
|
No anthocyanins
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LDL cholesterol
Time Frame: 28 days
|
Serum lipid status
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total/HDL cholesterol and triglycerides
Time Frame: 28 days
|
Serum lipid status and faecal excretion of lipids
|
28 days
|
Cholesterol efflux capacity
Time Frame: 28 days
|
Cholesterol metabolism
|
28 days
|
PON-1 activity
Time Frame: 28 days
|
Cholesterol metabolism
|
28 days
|
Bile acids and derivatives
Time Frame: 28 days
|
Plasma bile acid status and faecal excretion of bile acids
|
28 days
|
Glucose, fructosamine and insulin
Time Frame: 28 days
|
glycaemic control
|
28 days
|
MicroRNA expression
Time Frame: 28 days
|
MicroRNA's implicated in atherosclerosis, non-alcoholic fatty liver disease and reverse cholesterol transport
|
28 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul Kroon, Quadram Institute Bioscience
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFR01/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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