HyperlipidemiaNCT03213288
Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status
A study testing Delphinidin type anthocyanins and Cyanidin type anthocyanins in people with Hyperlipidemia, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
The primary aim of this study is to directly compare the two major types of anthocyanins found in the diet (cyanidin-type and delphinidin-type) on lipid status in adults. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Delphinidin type anthocyanins and Cyanidin type anthocyanins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Sep 2017to 30 Sep 2018
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ≥ 45 years of age
- Total cholesterol ≥ 5.0 mmol/L
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status in Adults
The primary aim of this study is to directly compare the two major types of anthocyanins found in the diet (cyanidin-type and delphinidin-type) on lipid status in adults.
Read the 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.
- Conditions
- Hyperlipidemia
- Being tested
- Delphinidin type anthocyanins, Cyanidin type anthocyanins, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphinidin type anthocyaninsDietary supplement
Bilberry extract containing Delphinidin type anthocyanins
Cyanidin type anthocyaninsDietary supplement
Black rice extract containing Cyanidin type anthocyanins
PlaceboDietary supplement
No anthocyanins
| Study group | Role | What they receive |
|---|---|---|
| Delphinidin type anthocyanins | Active comparator | Bilberry extract Receives: Dietary Supplement: Delphinidin type anthocyanins |
| Cyanidin type anthocyanins | Active comparator | Black rice extract Receives: Dietary Supplement: Cyanidin type anthocyanins |
| Placebo | Placebo comparator | No anthocyanins Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
Serum lipid status
Measured: 28 days
Secondary outcomes (6)
Total/HDL cholesterol and triglycerides
Serum lipid status and faecal excretion of lipids
Measured: 28 days
Cholesterol efflux capacity
Cholesterol metabolism
Measured: 28 days
PON-1 activity
Cholesterol metabolism
Measured: 28 days
Bile acids and derivatives
Plasma bile acid status and faecal excretion of bile acids
Measured: 28 days
Glucose, fructosamine and insulin
glycaemic control
Measured: 28 days
MicroRNA expression
MicroRNA's implicated in atherosclerosis, non-alcoholic fatty liver disease and reverse cholesterol transport
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start25 Sep 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Kroon, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213288
- Sponsor's protocol ID
- IFR01/2017
- Status last verified
- Dec 2019
- First submitted
- 5 Jul 2017
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status in Adults
- ClinicalTrials.gov ID
- NCT03213288
- Acronym / sponsor ID
- IFR01/2017
- Conditions
- Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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 primary aim of this study is to directly compare the two major types of anthocyanins found in the diet (cyanidin-type and delphinidin-type) on lipid status in adults.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delphinidin type anthocyanins | Active comparator | Dietary Supplement: Delphinidin type anthocyaninsBilberry extract |
| Cyanidin type anthocyanins | Active comparator | Dietary Supplement: Cyanidin type anthocyaninsBlack rice extract |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNo anthocyanins |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women ≥ 45 years of age
- Total cholesterol ≥ 5.0 mmol/L
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Delphinidin type anthocyaninsBilberry extract containing Delphinidin type anthocyanins | Dietary supplement | Delphinidin type anthocyanins |
| Cyanidin type anthocyaninsBlack rice extract containing Cyanidin type anthocyanins | Dietary supplement | Cyanidin type anthocyanins |
| PlaceboNo anthocyanins | Dietary supplement | Placebo |
Primary outcome
LDL cholesterol
Time frame: 28 days
Serum lipid status
6 secondary outcomes
Total/HDL cholesterol and triglycerides
Time frame: 28 days
Cholesterol efflux capacity
Time frame: 28 days
PON-1 activity
Time frame: 28 days
Bile acids and derivatives
Time frame: 28 days
Glucose, fructosamine and insulin
Time frame: 28 days
MicroRNA expression
Time frame: 28 days
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 10 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Paul Kroon principal investigator
Quadram Institute Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delphinidin type anthocyanins and Cyanidin type anthocyanins in people with Hyperlipidemia, run by Quadram Institute Bioscience at 1 site in United Kingdom.
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 2 inclusion and 15 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 10 Dec 2019. 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 United Kingdom. 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?
LDL cholesterol (time frame: 28 days). 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 10 Dec 2019.