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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03213288
Other study ID # IFR01/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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