Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status

Quadram Institute Bioscience

Status: Completed

Conditions: Hyperlipidemia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Delphinidin type anthocyanins; Dietary Supplement: Cyanidin type anthocyanins

Study type: Interventional

Funder types: Other

Identifiers

NCT03213288

IFR01/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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55 participants in 3 patient groups, including a placebo group

Delphinidin type anthocyanins

Active Comparator group

Description:

Bilberry extract

Treatment:

Dietary Supplement: Delphinidin type anthocyanins

Cyanidin type anthocyanins

Active Comparator group

Description:

Black rice extract

Treatment:

Dietary Supplement: Cyanidin type anthocyanins

Placebo

Placebo Comparator group

Description:

No anthocyanins

Treatment:

Dietary Supplement: Placebo