Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status

Not Applicable

Completed

• Conditions: Hyperlipidemia
• Interventions: Dietary Supplement: Cyanidin type anthocyanins; Dietary Supplement: Delphinidin type anthocyanins; Dietary Supplement: Placebo

• Registration Number: NCT03213288
• Lead Sponsor: Quadram Institute Bioscience

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.

Study Timeline

• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Study Start: 2017-09-25
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cyanidin type anthocyanins	Cyanidin type anthocyanins	Black rice extract
Delphinidin type anthocyanins	Delphinidin type anthocyanins	Bilberry extract
Placebo	Placebo	No anthocyanins

Primary Outcome Measures

Name	Time	Method
LDL cholesterol	28 days	Serum lipid status

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Quadram Institute Bioscience; 🇬🇧 Norwich, United Kingdom