Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants
Primary Purpose
Metabolic Syndrome, Insulin Resistance, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Montmorency Tart Cherry Juice
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Montmorency Tart Cherry, Anthocyanins, Polyphenols, Metabolic Syndrome, Insulin Resistance, Hypertension, Lipid Profile, Prediabetes
Eligibility Criteria
Inclusion Criteria:
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
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).
Sites / Locations
- University of Hertfordshire
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Montmorency Tart Cherry Juice
Arm Description
Outcomes
Primary Outcome Measures
Change in Fasting Insulin
Change in Systolic and Diastolic Blood Pressure
Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)
Change in Fasting Glucose
Secondary Outcome Measures
Change in 24-hour Ambulatory Blood Pressure
Systolic, Diastolic and Pulse Pressure will be measured
Change in HOMA2-IR, HOMA%S and HOMA%B
Homeostatic Model Assessment of Insulin Resistance, Sensitivity and Beta-cell function
Change in Pulse Wave Analysis
Change in Cardiac Haemodynamics
Beat-by-beat cardiac output, stroke volume, heart rate, total peripheral resistance, mean arterial pressure will be measured
Change in Resting Metabolic Rate
Change in Angiotensin Converting Enzyme Inhibition activity
Full Information
NCT ID
NCT03619941
First Posted
July 29, 2018
Last Updated
February 15, 2019
Sponsor
University of Hertfordshire
1. Study Identification
Unique Protocol Identification Number
NCT03619941
Brief Title
Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants
Official Title
Effects of 7-day Continuous Montmorency Tart Cherry Juice Supplementation in Metabolic Syndrome Participants: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
September 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hertfordshire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Insulin Resistance, Hypertension
Keywords
Montmorency Tart Cherry, Anthocyanins, Polyphenols, Metabolic Syndrome, Insulin Resistance, Hypertension, Lipid Profile, Prediabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Montmorency Tart Cherry Juice
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Montmorency Tart Cherry Juice
Intervention Description
100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water.
Concentrate contains no sweeteners, preservatives, flavourings or added sugar.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo drink attempted to match for total energy content, macronutrient content, appearance and taste of Montmorency tart cherry juice.
Primary Outcome Measure Information:
Title
Change in Fasting Insulin
Time Frame
Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Title
Change in Systolic and Diastolic Blood Pressure
Time Frame
Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
Title
Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)
Time Frame
Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Title
Change in Fasting Glucose
Time Frame
Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Secondary Outcome Measure Information:
Title
Change in 24-hour Ambulatory Blood Pressure
Description
Systolic, Diastolic and Pulse Pressure will be measured
Time Frame
Baseline, Post-Supplementation (7 days)
Title
Change in HOMA2-IR, HOMA%S and HOMA%B
Description
Homeostatic Model Assessment of Insulin Resistance, Sensitivity and Beta-cell function
Time Frame
Baseline, Post-Supplementation (7 days)
Title
Change in Pulse Wave Analysis
Time Frame
Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
Title
Change in Cardiac Haemodynamics
Description
Beat-by-beat cardiac output, stroke volume, heart rate, total peripheral resistance, mean arterial pressure will be measured
Time Frame
Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
Title
Change in Resting Metabolic Rate
Time Frame
Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
Title
Change in Angiotensin Converting Enzyme Inhibition activity
Time Frame
Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terun Desai
Organizational Affiliation
University of Hertfordshire
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hertfordshire
City
Hatfield
State/Province
Hertfordshire
ZIP/Postal Code
AL10 9AB
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
32789528
Citation
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.
Results Reference
derived
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Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants
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