Clinical Trials Directory

Trials / Terminated

TerminatedNCT03869086

Metabolism of Anthocyanins and Heart Health

The Effects of Blueberry Anthocyanin Metabolism on Acute Cardiometabolic Health

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
49 (actual)
Sponsor
University of East Anglia · Academic / Other
Sex
All
Age
50 Years – 80 Years
Healthy volunteers
Accepted

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 specifically aims to confirm if differences in how individuals process the bioactive compounds in blueberries, called anthocyanins, has an influence on heart health. The investigators will assess the effects of eating one portion of blueberries on vascular health over a 48hour period, and will track the breakdown compounds within blood and urine, to see if health effects are related to metabolism.

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 profiles confirmed in our previous studies) following a 'blueberry challenge'. Acute cardio and metabolic function responses will be assessed (by metaboliser profile), following an energy dense test meal with/without the addition of blueberries. Participants will be healthy, but overweight and obese (BMI inclusion: ≥ 25kg/m2) men and women (aged 50 y to 80 y), who will initially undertake a 'blueberry challenge' by consuming a single dose of freeze dried blueberries. Anthocyanin metaboliser type will be profiled from the analysis of metabolites within urine, collected for 48h following the 'challenge'. A total of 70 participants will complete the intervention (n=35 FAST and n=35 SLOW metabolisers) which consists of two, test meal periods (separated by at least 7d and allocated in random order); 1) energy dense test meal plus freeze dried blueberries, 2) energy dense test meal plus an isocaloric matched placebo material. Urine samples and ambulatory blood pressure measures will be collected for 24h prior to, and then over the 48h period which follows the test meal intake. Further assessment of vascular and metabolic function will be made at pre-defined times over the 48h postprandial period. Dietary restrictions to abstain from blueberries and reduce the anthocyanin intake level, will be applied for 5d before each test meal intake. In addition, all food and drink will be provided for a 4d period (2d before and during the 48h following the energy dense test meal) to further control the intake of flavonoids and to standardise the influence of background diet on metabolism profile.

Conditions

Interventions

TypeNameDescription
OTHERFreeze dried blueberry powder36 g of freeze-dried blueberry powder to be mixed with milk and served together with an energy-dense meal.
OTHERAnthocyanin free, sugar-matched placebo36 g of isocaloric placebo, matched for sugars to be mixed with milk and served together with an energy-dense meal.

Timeline

Start date
2019-06-04
Primary completion
2021-01-06
Completion
2021-01-06
First posted
2019-03-11
Last updated
2021-02-02

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03869086. Inclusion in this directory is not an endorsement.