Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants

NCT ID: NCT03619941

Last Updated: 2019-02-19

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2018-09-29

Brief Summary

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The present study examined the effect of Montmorency tart cherry juice on functional and blood-based cardio-metabolic markers in humans with Metabolic Syndrome. Participants consumed Montmorency tart cherry juice or a placebo beverage continuously for 7 days in a randomised, crossover trial. Outcome variables were measured immediately prior to supplementation and post-supplementation. Furthermore, on the 7th day of supplementation outcome variables were measured pre- and up to 5 hours post-bolus. It was hypothesised that Montmorency tart cherry juice would improve cardio-metabolic markers, particularly fasting insulin and systolic blood pressure. Furthermore, the study aimed to identify the mechanism of action for any effects of Montmorency tart cherry juice on blood pressure.

Detailed Description

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Conditions

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Metabolic Syndrome Insulin Resistance Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo drink attempted to match for total energy content, macronutrient content, appearance and taste of Montmorency tart cherry juice.

Montmorency Tart Cherry Juice

Group Type EXPERIMENTAL

Montmorency Tart Cherry Juice

Intervention Type DIETARY_SUPPLEMENT

100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water.

Concentrate contains no sweeteners, preservatives, flavourings or added sugar.

Interventions

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Montmorency Tart Cherry Juice

100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water.

Concentrate contains no sweeteners, preservatives, flavourings or added sugar.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo drink attempted to match for total energy content, macronutrient content, appearance and taste of Montmorency tart cherry juice.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education Program-Adult Treatment Panel III guidelines:

1. Waist Circumference: \>102cm (men), \>88cm (women)
2. Fasting Serum Triglycerides: ≥1.69 mmol.L-1
3. Fasting High Density Lipoprotein: \<1.03 mmol.L-1 (men), \<1.29 mmol.L-1 (women)
4. Blood Pressure: ≥130 mmHg SBP or ≥85 mmHg DBP
5. Fasting Plasma Glucose: ≥6.1 mmol.L-1

Exclusion Criteria

* Smokers
* Current or previous history of gastrointestinal, cardiovascular, hepatic or renal disease
* Currently diagnosed with diabetes or uncontrolled hypertension (≥160/100 mmHg)
* Allergy to fructose, maltodextrin or specific fruit products
* Currently taking medication (such as steroids, NSAIDs, antibiotics, antihypertensive, hypoglycaemic, lipid-lowering drugs)
* Currently using any nutritional or antioxidant supplement. Heavy alcohol consumption (\>14 units per week).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hertfordshire

OTHER

Sponsor Role lead

Responsible Party

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Terun Desai

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terun Desai

Role: PRINCIPAL_INVESTIGATOR

University of Hertfordshire

Locations

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University of Hertfordshire

Hatfield, Hertfordshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Desai T, Roberts M, Bottoms L. Effects of short-term continuous Montmorency tart cherry juice supplementation in participants with metabolic syndrome. Eur J Nutr. 2021 Apr;60(3):1587-1603. doi: 10.1007/s00394-020-02355-5. Epub 2020 Aug 12.

Reference Type DERIVED
PMID: 32789528 (View on PubMed)

Other Identifiers

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LMS/PGR/UH/03319

Identifier Type: -

Identifier Source: org_study_id

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