Clinical trial NCT03213288: Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status
Official title: The Effects of Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Lead sponsor: Quadram Institute Bioscience
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 55
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: LDL cholesterol
timeFrame: 28 days
Secondary outcomes:
measure: Total/HDL cholesterol and triglycerides
timeFrame: 28 days
measure: Cholesterol efflux capacity
timeFrame: 28 days
measure: PON-1 activity
timeFrame: 28 days
measure: Bile acids and derivatives
timeFrame: 28 days
measure: Glucose, fructosamine and insulin
timeFrame: 28 days
measure: MicroRNA expression
timeFrame: 28 days
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Quadram Institute Bioscience
Study officials:
affiliation: Quadram Institute Bioscience
name: Paul Kroon
role: PRINCIPAL_INVESTIGATOR
References: