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Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status

Primary Purpose

Hyperlipidemia

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Delphinidin type anthocyanins

Cyanidin type anthocyanins

Placebo

About this trial

This is an interventional prevention trial for Hyperlipidemia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Quadram Institute Bioscience

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Delphinidin type anthocyanins

Cyanidin type anthocyanins

Placebo

Arm Description

Bilberry extract

Black rice extract

No anthocyanins

Outcomes

Primary Outcome Measures

LDL cholesterol

Serum lipid status

Secondary Outcome Measures

Total/HDL cholesterol and triglycerides

Serum lipid status and faecal excretion of lipids

Cholesterol efflux capacity

Cholesterol metabolism

PON-1 activity

Cholesterol metabolism

Bile acids and derivatives

Plasma bile acid status and faecal excretion of bile acids

Glucose, fructosamine and insulin

glycaemic control

MicroRNA expression

MicroRNA's implicated in atherosclerosis, non-alcoholic fatty liver disease and reverse cholesterol transport

Full Information

NCT ID

NCT03213288

First Posted

July 5, 2017

Last Updated

December 9, 2019

Sponsor

Quadram Institute Bioscience

1. Study Identification

Unique Protocol Identification Number

NCT03213288

Brief Title

Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status

Official Title

The Effects of Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

September 25, 2017 (Actual)

Primary Completion Date

September 30, 2018 (Actual)

Study Completion Date

September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Quadram Institute Bioscience

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Delphinidin type anthocyanins

Arm Type

Active Comparator

Arm Description

Bilberry extract

Arm Title

Cyanidin type anthocyanins

Arm Type

Active Comparator

Arm Description

Black rice extract

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

No anthocyanins

Intervention Type

Dietary Supplement

Intervention Name(s)

Delphinidin type anthocyanins

Intervention Description

Bilberry extract containing Delphinidin type anthocyanins

Intervention Type

Dietary Supplement

Intervention Name(s)

Cyanidin type anthocyanins

Intervention Description

Black rice extract containing Cyanidin type anthocyanins

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

No anthocyanins

Primary Outcome Measure Information:

Title

LDL cholesterol

Description

Serum lipid status

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Total/HDL cholesterol and triglycerides

Description

Serum lipid status and faecal excretion of lipids

Time Frame

28 days

Title

Cholesterol efflux capacity

Description

Cholesterol metabolism

Time Frame

28 days

Title

PON-1 activity

Description

Cholesterol metabolism

Time Frame

28 days

Title

Bile acids and derivatives

Description

Plasma bile acid status and faecal excretion of bile acids

Time Frame

28 days

Title

Glucose, fructosamine and insulin

Description

glycaemic control

Time Frame

28 days

Title

MicroRNA expression

Description

MicroRNA's implicated in atherosclerosis, non-alcoholic fatty liver disease and reverse cholesterol transport

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Kroon

Organizational Affiliation

Quadram Institute Bioscience

Official's Role

Principal Investigator

Facility Information:

Facility Name

Quadram Institute Bioscience

City

Norwich

ZIP/Postal Code

NR4 7UA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status

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