NCT03213288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

July 5, 2017

Last Update Submit

December 9, 2019

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • LDL cholesterol

    Serum lipid status

    28 days

Secondary Outcomes (6)

  • Total/HDL cholesterol and triglycerides

    28 days

  • Cholesterol efflux capacity

    28 days

  • PON-1 activity

    28 days

  • Bile acids and derivatives

    28 days

  • Glucose, fructosamine and insulin

    28 days

  • +1 more secondary outcomes

Study Arms (3)

Delphinidin type anthocyanins

ACTIVE COMPARATOR

Bilberry extract

Dietary Supplement: Delphinidin type anthocyanins

Cyanidin type anthocyanins

ACTIVE COMPARATOR

Black rice extract

Dietary Supplement: Cyanidin type anthocyanins

Placebo

PLACEBO COMPARATOR

No anthocyanins

Dietary Supplement: Placebo

Interventions

Delphinidin type anthocyaninsDIETARY_SUPPLEMENT

Bilberry extract containing Delphinidin type anthocyanins

Delphinidin type anthocyanins
Cyanidin type anthocyaninsDIETARY_SUPPLEMENT

Black rice extract containing Cyanidin type anthocyanins

Cyanidin type anthocyanins
PlaceboDIETARY_SUPPLEMENT

No anthocyanins

Placebo

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ≥ 45 years of age
  • Total cholesterol ≥ 5.0 mmol/L

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quadram Institute Bioscience

Norwich, NR4 7UA, United Kingdom

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Paul Kroon

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 11, 2017

Study Start

September 25, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

December 10, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)