Clinical trial NCT03619941: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Insulin Resistance
Hypertension
Keywords: Montmorency Tart Cherry
Anthocyanins
Polyphenols
Metabolic Syndrome
Insulin Resistance
Hypertension
Lipid Profile
Prediabetes
Lead sponsor: University of Hertfordshire
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Fasting Insulin
timeFrame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
measure: Change in Systolic and Diastolic Blood Pressure
timeFrame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
measure: Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)
timeFrame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
measure: Change in Fasting Glucose
timeFrame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Secondary outcomes:
measure: Change in 24-hour Ambulatory Blood Pressure
timeFrame: Baseline, Post-Supplementation (7 days)
measure: Change in HOMA2-IR, HOMA%S and HOMA%B
timeFrame: Baseline, Post-Supplementation (7 days)
measure: Change in Pulse Wave Analysis
timeFrame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
measure: Change in Cardiac Haemodynamics
timeFrame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
measure: Change in Resting Metabolic Rate
timeFrame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
measure: Change in Angiotensin Converting Enzyme Inhibition activity
timeFrame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Other outcomes:
Locations:
city: Hatfield
country: United Kingdom
facility: University of Hertfordshire
state: Hertfordshire
Study officials:
affiliation: University of Hertfordshire
name: Terun Desai
role: PRINCIPAL_INVESTIGATOR
References:
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.