Metabolism of Anthocyanins and Heart Health

NCT03869086 | Terminated

• 1 other identifier: AMP001_22NOV2018
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy

Keywords

Blueberry; Metabolism; Anthocyanins; Inter-individual variation; Cardiometabolic health

Outcome Measures

Primary Outcomes (1)

• Brachial artery endothelial function

  percentage maximum dilatation assessed via flow mediated dilation (%FMD): (diametermax-diameterbaseline) / diameterbaseline×100.

  assessed at 0, 1.5, 3, 6, 24, 48 hours after intervention intake

Secondary Outcomes (4)

• Office blood pressure

  Assessed at 0, 3, 6, 24, 48 hours after intervention intake.

• Bioavailability - serum

  Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.

• Postprandial Insulin response

  Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.

• Total cholesterol

  Measured prior to, and then at +20, +40, +60, +90, +120, +180, +270 and +360 minutes, +24 hours and +48 hours following the energy dense meal intake.

Other Outcomes (9)

• Microbiome assessment of phyla and species

  Sample collected up to 2 days prior to test meal 1 and assessed within 5 years of study completion

• Ambulatory blood pressure

  1 day before, and the two days following the intake of each energy dense test meal

• Aortic arterial stiffness (cf-PWV)

  assessed at 0, 3, 6, 24, 48 hours after intervention intake

Study Arms (2)

SLOW anthocyanin metabolisers

EXPERIMENTAL

Participants will be prospectively recruited to the SLOW anthocyanin metaboliser group, following a pre-intervention screen (blueberry challenge). Participants in this arm will consume (in random order) blueberry and placebo interventions (both consumed with an energy dense meal) in a cross-over manner. At least 7 days washout will be observed between the two treatments.

Other: Freeze dried blueberry powder; Other: Anthocyanin free, sugar-matched placebo

FAST anthocyanin metabolisers

EXPERIMENTAL

Participants will be prospectively recruited to the FAST anthocyanin metaboliser group, following a pre-intervention screen (blueberry challenge). Participants in this arm will consume (in random order) blueberry and placebo interventions (both consumed with an energy dense meal) in a cross-over manner. At least 7 days washout will be observed between the two treatments.

Other: Freeze dried blueberry powder; Other: Anthocyanin free, sugar-matched placebo

Interventions

Freeze dried blueberry powder OTHER

36 g of freeze-dried blueberry powder to be mixed with milk and served together with an energy-dense meal.

FAST anthocyanin metabolisers; SLOW anthocyanin metabolisers

Anthocyanin free, sugar-matched placebo OTHER

36 g of isocaloric placebo, matched for sugars to be mixed with milk and served together with an energy-dense meal.

FAST anthocyanin metabolisers; SLOW anthocyanin metabolisers

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \>= 25 kg/m2
• Adults aged 50 - 80 years old
• Successful biochemical, haematological, and urinalysis assessment at screening

You may not qualify if:

• 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

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (1)

Quadram Institute Clinical Research Facility; a partnership facility of the NHS, UEA and QIB

Norwich, Norfolk, NR4 7UQ, United Kingdom

Location

Study Officials

• Aedin Cassidy, PhD

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomised allocation of treatment order for each participant will be performed by an independent researcher with experience in statistical randomisation. The Principle Investigator will receive notification of the treatment coding order for each subject (in a tamper-evident sealed envelope) which will be prepared by the independent researcher trained in statistics. The coding of the treatment randomisation will only be known to this researcher; and will only be broken at the analysis stage of the study unless a serious adverse event occurs. As the intervention material is a powdered food product, or placebo material, it is considered unlikely that this eventuality may occur. During the analysis stage, a blind review of data quality and outlier data will be performed prior to unblinding. Researchers analysing the raw data will remain blind and the data will be locked prior to unblinding of the statistician (which will only occur after the completion of the statistical analysis).
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Our research design involves screening individuals and then prospectively recruiting on the basis of two distinct blueberry metabolism profiles based on our previous research findings (in a population with metabolic syndrome). Our study will assess whether individuals with SLOW and FAST anthocyanin metabolism profiles respond differently and will test if the difference in processing may influence cardio metabolic responses. Our study involves feeding a single energy-dense meal which we anticipate will have a transient deleterious effect on acute markers of health. We will test whether adding blueberries to the energy dense meal improves acute responses compared against when adding the equivalent isocaloric amount of placebo. Participants will experience the blueberry and placebo treatments in random order

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 11, 2019
• Study Start: June 4, 2019
• Primary Completion: January 6, 2021
• Study Completion: January 6, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

GB (1)