Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

NCT ID: NCT04177238

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2022-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. Anthocyanins, found in high quantities in both tart cherries and blueberries are powerful antioxidants, that are potentially capable of improving cardiometabolic dysfunction. However, to date, no research has explored the cardiometabolic responses to tart cherry and blueberry supplementation.

Therefore, the primary purpose of the proposed investigation is to test the ability of oral tart cherry and blueberry supplementation to improve cardiometabolic parameters in healthy individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Identical in taste and colour to the supplement juice, but with no anthocyanin content

Group Type PLACEBO_COMPARATOR

Fruit concentrate - either cherry or blueberry

Intervention Type DIETARY_SUPPLEMENT

Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).

Cherry juice

30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,

Group Type EXPERIMENTAL

Fruit concentrate - either cherry or blueberry

Intervention Type DIETARY_SUPPLEMENT

Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).

Blueberry

30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,

Group Type EXPERIMENTAL

Fruit concentrate - either cherry or blueberry

Intervention Type DIETARY_SUPPLEMENT

Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fruit concentrate - either cherry or blueberry

Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy
* 18 years of age and above
* Non-smoker
* BMI \< 30
* Able to give informed consent

Exclusion Criteria

* Pregnancy
* Diabetes or any other metabolic/ uncontrolled hypertensive conditions
* Food allergies to cherries or blueberries
* Habitual consumption of blueberries/ cherries and/or blueberry/ cherry products
* Not regularly taking medication or antioxidant supplements
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Central Lancashire

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jonathan Sinclair

Principal Investigator - Professor of Sport, Exercise & Nutritional Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Central Lancashire

Preston, Lancashire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Sinclair J, Shadwell G, Dillon S, Allan R, Butters B, Bottoms L. Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic Outcomes in Healthy Individuals: Protocol for a 3-Arm Placebo Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Sep 16;18(18):9759. doi: 10.3390/ijerph18189759.

Reference Type DERIVED
PMID: 34574679 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Cherry/ blueberry concentrate

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Smoothies and Blood Sugars
NCT06333184 COMPLETED NA
Effects of Green Tea on Cardiometabolic Outcomes
NCT06795438 NOT_YET_RECRUITING NA