Acute Cardio-metabolic Responses to Montmorency Tart Cherry Supplementation in Metabolic Syndrome Patients

NCT03615885 | Completed

• 1 other identifier: LMS/PGT/UH/02843
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The present study examined the effect of Montmorency tart cherry juice and capsules on functional and blood-based cardio-metabolic markers in humans with Metabolic Syndrome. Participants received a single bolus of Montmorency tart cherry juice, Montmorency tart cherry capsules and placebo in a random, crossover trial. Outcome variables were measured immediately pre- and up to 5 hours post-bolus. It was hypothesised that Montmorency tart cherry juice and capsules would improve cardio-metabolic markers. Furthermore, it was hypothesised that Montmorency tart cherry capsules would be more beneficial than Montmorency tart cherry juice due to increased bioavailability of phytochemicals.

Conditions

Metabolic Syndrome; Insulin Resistance; Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in Fasting Insulin

  Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)

• Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)

  Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)

• Change in Fasting Glucose

  Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)

• Change in Systolic and Diastolic Blood Pressure

  Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

Secondary Outcomes (10)

• Change in Augmentation Index

  Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

• Change in Aortic Systolic and Diastolic Pressure

  Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

• Change in Augmentation Pressure

  Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

• Change in Cardiac Output

  Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

• Change in Stroke Volume

  Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

Study Arms (3)

Placebo Drink

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Montmorency Tart Cherry Capsules

EXPERIMENTAL

10 capsules consumed to match total anthocyanin content to Montmorency tart cherry juice.

Dietary Supplement: Montmorency Tart Cherry Capsules

Montmorency Tart Cherry Juice

EXPERIMENTAL

Single-bolus of Montmorency tart cherry juice (130 mL)

Dietary Supplement: Montmorency Tart Cherry Juice

Interventions

Montmorency Tart Cherry Capsules DIETARY_SUPPLEMENT

Capsules are made from 100% natural, tart Montmorency cherries. Carefully prepared Montmorency cherry skins are freeze-dried and milled into a fine powder to protect the cherry phytonutrients and optimise absorbtion. This powder is then encapsulated into a 100% vegetarian shell.

Montmorency Tart Cherry Capsules

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

130ml serving Placebo composition: Water (100ml), Cherry Cordial Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml).

Placebo Drink

Eligibility Criteria

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

You may qualify if:

• Non-smoker,
• 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:

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

Sponsors & Collaborators

• University of Hertfordshire: lead
• Heart UK: collaborator

Study Sites (1)

University of Hertfordshire

Hatfield, AL10 9AB, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Hypertension

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

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 20, 2018
• First Posted: August 6, 2018
• Study Start: June 6, 2017
• Primary Completion: October 15, 2017
• Study Completion: December 1, 2017
• Last Updated: August 6, 2018

Record last verified: 2018-07

Locations

GB (1)