Effects of Oral Fruit Concentrate Supplementation in Pre-Metabolic Syndrome.

NCT07815847 | Completed

• 1 other identifier: Fruit Concentrate pre-mets
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease, type 2 diabetes mellitus and associated metabolic diseases are leading causes of morbidity and mortality worldwide; therefore, effective preventive interventions are required. Pre-metabolic syndrome, characterised by the presence of two metabolic syndrome components, represents an important opportunity for intervention before progression to metabolic syndrome and overt cardiometabolic disease. Dietary interventions are particularly sought after because they generally carry less risk than pharmacological treatments. Anthocyanins, found in high concentrations in tart cherries and blueberries, possess antioxidant and anti-inflammatory properties that may improve cardiometabolic health. However, the cardiometabolic effects of tart cherry and blueberry supplementation have not been directly compared in individuals with pre-metabolic syndrome. Therefore, the primary purpose of the proposed investigation is to compare the ability of oral tart cherry and blueberry supplementation to improve cardiometabolic parameters in individuals with pre-metabolic syndrome.

Conditions

Pre-metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• Systolic blood pressure

  Systolic blood pressure - measured using a digital blood pressure monitor

  Baseline

• Systolic blood pressure

  Systolic blood pressure - measured using a digital blood pressure monitor

  20 days

Secondary Outcomes (38)

• Diastolic blood pressure

  Baseline

• Diastolic blood pressure

  20 days

• Percent bodyfat and fat mass

  Baseline

• Percent bodyfat and fat mass

  20 days

• Waist circumference

  Baseline

Study Arms (3)

Blueberry

EXPERIMENTAL

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

Dietary Supplement: Blueberry

Cherry

EXPERIMENTAL

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

Dietary Supplement: Cherry

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Blueberry DIETARY_SUPPLEMENT

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

Blueberry

Cherry DIETARY_SUPPLEMENT

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

Cherry

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years. Meet two of the five metabolic syndrome criteria. Not taking prescribed medication specifically intended to manage blood pressure, blood glucose or blood lipids.
• Able to complete written questionnaires independently. Able to provide informed consent.

You may not qualify if:

• Diagnosed diabetes mellitus. Known cardiovascular disease or clinically significant cardiovascular comorbidity, including coronary heart disease, symptomatic heart failure, clinically significant arrhythmia, or a history of stroke or transient ischaemic attack within the previous six months.
• Known or suspected secondary hypertension, including renal, renovascular or endocrine causes.
• Known clinically significant renal impairment or severe hepatic disease. Evidence or history of hypertension-related target-organ damage requiring specialist management.
• Pregnant or lactating. Allergy or known intolerance to tart cherry/ blueberry or any ingredient contained in the intervention or placebo.
• Habitual consumption of tart cherry/ blueberry products. Regular consumption of antioxidant or other dietary supplements likely to influence cardiometabolic outcomes.
• Body mass index greater than 40.0 kg/m². Current enrolment in another clinical trial or use of another intervention or therapy likely to influence the study outcomes.
• Any condition likely to compromise informed consent, protocol compliance or outcome assessment, including severe psychiatric illness, cognitive impairment, or active substance or alcohol misuse.

Sponsors & Collaborators

• University of Central Lancashire: lead

Study Sites (1)

University of Central Lancashire

Preston, United Kingdom

Location

MeSH Terms

Interventions

blueberry extract

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: May 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)