Metabolic SyndromeNCT03615885

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

A study testing Montmorency Tart Cherry Capsules and Montmorency Tart Cherry Juice in people with Metabolic Syndrome and Insulin Resistance, run by University of Hertfordshire at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Metabolic Syndrome, Insulin Resistance, Hypertension
What is being tested?: Montmorency Tart Cherry Capsules and Montmorency Tart Cherry Juice
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteUnited Kingdom
Study dates: 6 Jun 2017to 1 Dec 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

University of Hertfordshire
Hatfield, AL10 9AB

Other trials in United Kingdom

About this study

Official title: Acute Cardio-metabolic Responses to Different Forms of Montmorency Tart Cherry Supplementation in Humans With Metabolic Syndrome

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
Being tested: Montmorency Tart Cherry Capsules, Montmorency Tart Cherry Juice, Placebo
Keywords: Montmorency Tart Cherry, Anthocyanins, Polyphenols, Metabolic Syndrome, Insulin Resistance, Hypertension, Lipid Profile
Medical subject headings: Metabolic Syndrome, Insulin Resistance, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Montmorency Tart Cherry CapsulesDietary 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 JuiceDietary supplement
100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water.
Concentrate contains no sweeteners, preservatives, flavourings or added sugar.
PlaceboDietary supplement
130ml serving
Placebo composition: Water (100ml), Cherry Cordial Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml).

Study groups in NCT03615885
Study group	Role	What they receive
Placebo Drink	Placebo comparator	Placebo drink attempted to match for total energy, appearance and taste of Montmorency tart cherry juice. Receives: Dietary Supplement: Placebo
Montmorency Tart Cherry Capsules	Experimental	10 capsules consumed to match total anthocyanin content to Montmorency tart cherry juice. Receives: Dietary Supplement: Montmorency Tart Cherry Capsules
Montmorency Tart Cherry Juice	Experimental	Single-bolus of Montmorency tart cherry juice (130 mL) Receives: Dietary Supplement: Montmorency Tart Cherry Juice

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Fasting Insulin
Measured: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)
Measured: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Change in Fasting Glucose
Measured: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Change in Systolic and Diastolic Blood Pressure
Measured: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

Secondary outcomes (10)

Change in Augmentation Index
Measure of arterial stiffness and central blood pressures
Measured: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Aortic Systolic and Diastolic Pressure
Measure of arterial stiffness and central blood pressures
Measured: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Augmentation Pressure
Measure of arterial stiffness and central blood pressures
Measured: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Cardiac Output
Beat-to-beat resting cardiac haemodynamics (cardiac output, mean arterial pressure, strove volume, total peripheral resistance, heart rate)
Measured: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Stroke Volume
Beat-to-beat resting cardiac haemodynamics
Measured: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Heart Rate
Beat-to-beat resting cardiac haemodynamics
Measured: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Mean Arterial Pressure
Beat-to-beat resting cardiac haemodynamics
Measured: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Total Peripheral Resistance
Beat-to-beat resting cardiac haemodynamics
Measured: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Resting Energy Expenditure
Measured from indirect calorimetry
Measured: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Respiratory Quotient
Measured from indirect calorimetry
Measured: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 20171 Dec 2017

First posted6 Aug 2018
Study start6 Jun 2017
Primary completion15 Oct 2017
Study completion1 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03615885
Sponsor's protocol ID: LMS/PGT/UH/02843
Status last verified: Jul 2018
First submitted: 20 Jul 2018
Last updated: 6 Aug 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Cardio-metabolic Responses to Different Forms of Montmorency Tart Cherry Supplementation in Humans With Metabolic Syndrome
ClinicalTrials.gov ID: NCT03615885
Acronym / sponsor ID: LMS/PGT/UH/02843
Conditions: Metabolic Syndrome, Insulin Resistance, Hypertension
Keywords: Montmorency Tart Cherry, Anthocyanins, Polyphenols, Metabolic Syndrome, Insulin Resistance, Hypertension, Lipid Profile
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: University of HertfordshireUniversity, hospital or other
Collaborators: Heart UK
Study start: 6 Jun 2017 (actual)
Primary completion: 15 Oct 2017 (actual)
Study completion: 1 Dec 2017 (actual)
First posted: 6 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo Drink	Placebo comparator	Dietary Supplement: PlaceboPlacebo drink attempted to match for total energy, appearance and taste of Montmorency tart cherry juice.
Montmorency Tart Cherry Capsules	Experimental	Dietary Supplement: Montmorency Tart Cherry Capsules10 capsules consumed to match total anthocyanin content to Montmorency tart cherry juice.
Montmorency Tart Cherry Juice	Experimental	Dietary Supplement: Montmorency Tart Cherry JuiceSingle-bolus of Montmorency tart cherry juice (130 mL)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (1 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Montmorency Tart Cherry CapsulesCapsules 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.	Dietary supplement	Montmorency Tart Cherry Capsules
Montmorency Tart Cherry Juice100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water. Concentrate contains no sweeteners, preservatives, flavourings or added sugar.	Dietary supplement	Montmorency Tart Cherry Juice
Placebo130ml serving Placebo composition: Water (100ml), Cherry Cordial Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml).	Dietary supplement	Placebo Drink

Primary outcome

Change in Fasting Insulin
Time frame: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)
Time frame: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Change in Fasting Glucose
Time frame: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Change in Systolic and Diastolic Blood Pressure
Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

10 secondary outcomes

Change in Augmentation Index
Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Aortic Systolic and Diastolic Pressure
Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Augmentation Pressure
Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Cardiac Output
Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Stroke Volume
Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Heart Rate
Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Mean Arterial Pressure
Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Total Peripheral Resistance
Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Resting Energy Expenditure
Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Respiratory Quotient
Time frame: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fasting Insulin (time frame: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03615885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.