Metabolism of Anthocyanins and Heart Health

Healthy Clinical Trial

— AMP  

Official title:

The Effects of Blueberry Anthocyanin Metabolism on Acute Cardiometabolic Health

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03869086
• Other study ID #: AMP001_22NOV2018
• Status: Terminated
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: January 6, 2021

Study information

• Verified date: January 2021
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• BMI >= 25 kg/m2

• Adults aged 50 - 80 years old

• Successful biochemical, haematological, and urinalysis assessment at screening

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Freeze dried blueberry powder
36 g of freeze-dried blueberry powder to be mixed with milk and served together with an energy-dense meal.
• Anthocyanin free, sugar-matched placebo
36 g of isocaloric placebo, matched for sugars to be mixed with milk and served together with an energy-dense meal.

Locations

Country	Name	City	State
United Kingdom	Quadram Institute Clinical Research Facility; a partnership facility of the NHS, UEA and QIB	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microbiome assessment of phyla and species	Assessment of the gut microbiome from faecal samples collected from FAST and SLOW anthocyanin metabolisers.	Sample collected up to 2 days prior to test meal 1 and assessed within 5 years of study completion
Other	Ambulatory blood pressure	Measurement of pre-intervention and postprandial ambulatory blood pressure	1 day before, and the two days following the intake of each energy dense test meal
Other	Aortic arterial stiffness (cf-PWV)	Measurement of carotid to femoral pulse wave velocity	assessed at 0, 3, 6, 24, 48 hours after intervention intake
Other	Systemic arterial stiffness (AIx)	Measurement of brachial augmentation index (adjusted to 75 beats per minute heart rate)	assessed at 0, 3, 6, 24, 48 hours after intervention intake
Other	Bioavailability - urine	Assessment of flavonoid and metabolite levels in 24 hour urine samples	3 days during the blueberry challenge (1 day before and the two days of the assessment) and 3 days during each test meal assessment (1 day before and the two days of the assessment)
Other	Postprandial glucose response	Assessment of postprandial glucsoe control	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	High density lipoprotein cholesterol	Assessment of blood high density lipoprotein 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	Triglycerides	Assessment of blood triglycerides	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	Low density lipoprotein cholesterol	Assessment of blood low density lipoprotein 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.
Primary	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	Office blood pressure	Measurements of blood pressure	Assessed at 0, 3, 6, 24, 48 hours after intervention intake.
Secondary	Bioavailability - serum	Assessment of flavonoid and metabolite levels in blood samples	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.
Secondary	Postprandial Insulin response	Assessment of postprandial insulin control	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.
Secondary	Total cholesterol	Assessment of blood 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.