Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213288
• Other study ID #: IFR01/2017
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: December 2019
• Source: Quadram Institute Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Delphinidin type anthocyanins
Bilberry extract containing Delphinidin type anthocyanins
• Cyanidin type anthocyanins
Black rice extract containing Cyanidin type anthocyanins
• Placebo
No anthocyanins

Locations

Country	Name	City	State
United Kingdom	Quadram Institute Bioscience	Norwich

Sponsors (1)

Lead Sponsor	Collaborator
Quadram Institute Bioscience

Country where clinical trial is conducted

United Kingdom, 

Outcome

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