Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants

Effects of 7-day Continuous Montmorency Tart Cherry Juice Supplementation in Metabolic Syndrome Participants: a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Metabolic Syndrome; Insulin Resistance
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Montmorency Tart Cherry Juice

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hertfordshire
    • Hatfield, Hertfordshire, United Kingdom, AL10 9AB
      • University of Hertfordshire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo drink attempted to match for total energy content, macronutrient content, appearance and taste of Montmorency tart cherry juice.
Experimental: Montmorency Tart Cherry Juice	Dietary supplement: Montmorency Tart Cherry Juice; 100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water. Concentrate contains no sweeteners, preservatives, flavourings or added sugar.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Fasting Insulin	Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Change in Systolic and Diastolic Blood Pressure	Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)	Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Change in Fasting Glucose	Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24-hour Ambulatory Blood Pressure	Systolic, Diastolic and Pulse Pressure will be measured	Baseline, Post-Supplementation (7 days)
Change in HOMA2-IR, HOMA%S and HOMA%B	Homeostatic Model Assessment of Insulin Resistance, Sensitivity and Beta-cell function	Baseline, Post-Supplementation (7 days)
Change in Pulse Wave Analysis		Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
Change in Cardiac Haemodynamics	Beat-by-beat cardiac output, stroke volume, heart rate, total peripheral resistance, mean arterial pressure will be measured	Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
Change in Resting Metabolic Rate		Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
Change in Angiotensin Converting Enzyme Inhibition activity		Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)

Collaborators and Investigators

• Sponsor: University of Hertfordshire
• Investigators: Principal Investigator: Terun Desai, University of Hertfordshire

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): September 29, 2018

Study Registration Dates

• First Submitted: July 29, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 15, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Prediabetes; Hypertension; Insulin Resistance; Metabolic Syndrome; Polyphenols; Anthocyanins; Lipid Profile; Montmorency Tart Cherry
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Hyperinsulinism; Hypertension; Syndrome; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: LMS/PGR/UH/03319

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No