Status:
TERMINATED
Metabolism of Anthocyanins and Heart Health
Lead Sponsor:
University of East Anglia
Conditions:
Healthy
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
This study aims to find out if consuming a single dose of blueberries, rich in anthocyanins, within an energy dense meal, improves blood vessel function and biomarkers of heart health. The study speci...
Detailed Description
The primary aim of this cross-over designed, placebo controlled, acute dietary intervention study, is to prospectively recruit participants on the basis of anthocyanin metabolism profiles (based on pr...
Eligibility Criteria
Inclusion
- BMI \>= 25 kg/m2
- Adults aged 50 - 80 years old
- Successful biochemical, haematological, and urinalysis assessment at screening
Exclusion
- Current smokers, or ex-smokers ceasing \< 6 months ago
- existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures
- Fructose or lactose intolerant subjects or known allergies to intervention treatments
- Those unprepared to adhere to dietary instructions
- Parallel participation in another research project involving dietary intervention and/or sampling of biological fluids/material
- Those on therapeutic diets or having experienced substantial weight loss within 2 months of screening.
- Those taking flavonoid, nitrate / nitrite containing or fish oil containing supplements (and unwilling to cease intake during, and 1 month preceding the trial) or unwilling to maintain existing intake of other supplements.
- Prescribed hypoglycaemic, anti-hypertensive, vasodilator or hormone replacement therapy (HRT) medication.
- Unsatisfactory biochemical, haematological or urinary results or measurements considered to be counter indicative for the study
- Undiagnosed hypertension (elicited at screening; i.e. ≥ 180 / 110mmHg) at a level requiring immediate referral back to general practitioner for follow-up
Key Trial Info
Start Date :
June 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03869086
Start Date
June 4 2019
End Date
January 6 2021
Last Update
February 2 2021
Active Locations (1)
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1
Quadram Institute Clinical Research Facility; a partnership facility of the NHS, UEA and QIB
Norwich, Norfolk, United Kingdom, NR4 7UQ