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

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Dietary supplement: Delphinidin type anthocyanins; Dietary supplement: Cyanidin type anthocyanins; Dietary supplement: Placebo

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: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Norwich, United Kingdom, NR4 7UA
    • Quadram Institute Bioscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Delphinidin type anthocyanins; Bilberry extract	Dietary supplement: Delphinidin type anthocyanins; Bilberry extract containing Delphinidin type anthocyanins
Active Comparator: Cyanidin type anthocyanins; Black rice extract	Dietary supplement: Cyanidin type anthocyanins; Black rice extract containing Cyanidin type anthocyanins
Placebo Comparator: Placebo; No anthocyanins	Dietary supplement: Placebo; No anthocyanins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL cholesterol	Serum lipid status	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total/HDL cholesterol and triglycerides	Serum lipid status and faecal excretion of lipids	28 days
Cholesterol efflux capacity	Cholesterol metabolism	28 days
PON-1 activity	Cholesterol metabolism	28 days
Bile acids and derivatives	Plasma bile acid status and faecal excretion of bile acids	28 days
Glucose, fructosamine and insulin	glycaemic control	28 days
MicroRNA expression	MicroRNA's implicated in atherosclerosis, non-alcoholic fatty liver disease and reverse cholesterol transport	28 days

Collaborators and Investigators

• Sponsor: Quadram Institute Bioscience
• Investigators: Principal Investigator: Paul Kroon, Quadram Institute Bioscience

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: IFR01/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No