Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants

NCT03619941 | Completed

• 1 other identifier: LMS/PGR/UH/03319
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome; Insulin Resistance; Hypertension

Keywords

Montmorency Tart Cherry; Anthocyanins; Polyphenols; Metabolic Syndrome; Insulin Resistance; Hypertension; Lipid Profile; Prediabetes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Change in 24-hour Ambulatory Blood Pressure

  Baseline, Post-Supplementation (7 days)

• Change in HOMA2-IR, HOMA%S and HOMA%B

  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

  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)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Montmorency Tart Cherry Juice

EXPERIMENTAL

Dietary Supplement: Montmorency Tart Cherry Juice

Interventions

Montmorency Tart Cherry Juice DIETARY_SUPPLEMENT

100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water. Concentrate contains no sweeteners, preservatives, flavourings or added sugar.

Montmorency Tart Cherry Juice

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education Program-Adult Treatment Panel III guidelines:
• Waist Circumference: \>102cm (men), \>88cm (women)
• Fasting Serum Triglycerides: ≥1.69 mmol.L-1
• Fasting High Density Lipoprotein: \<1.03 mmol.L-1 (men), \<1.29 mmol.L-1 (women)
• Blood Pressure: ≥130 mmHg SBP or ≥85 mmHg DBP
• Fasting Plasma Glucose: ≥6.1 mmol.L-1

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Hertfordshire: lead

Study Sites (1)

University of Hertfordshire

Hatfield, Hertfordshire, AL10 9AB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32789528 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Hypertension; Prediabetic State

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Terun Desai

  University of Hertfordshire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 8, 2018
• Study Start: May 15, 2018
• Primary Completion: September 20, 2018
• Study Completion: September 29, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

GB (1)