Metabolic SyndromeNCT03619941
Continuous Tart Cherry Juice Supplementation With Metabolic Syndrome Participants
A study testing Montmorency Tart Cherry Juice in people with Metabolic Syndrome and Insulin Resistance, run by University of Hertfordshire at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome, Insulin Resistance, Hypertension
- What is being tested?
- Montmorency Tart Cherry Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2018to 29 Sep 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Hertfordshire
Hatfield, Hertfordshire, AL10 9AB
About this study
Official title: Effects of 7-day Continuous Montmorency Tart Cherry Juice Supplementation in Metabolic Syndrome Participants: a Pilot Study
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
- Being tested
- Montmorency Tart Cherry Juice, Placebo
- Keywords
- Montmorency Tart Cherry, Anthocyanins, Polyphenols, Metabolic Syndrome, Insulin Resistance, Hypertension, Lipid Profile, Prediabetes
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Hypertension, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Placebo drink attempted to match for total energy content, macronutrient content, appearance and taste of Montmorency tart cherry juice.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Montmorency Tart Cherry Juice | Experimental | Not described 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: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Change in Systolic and Diastolic Blood Pressure
Measured: 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)
Measured: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Change in Fasting Glucose
Measured: 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
Systolic, Diastolic and Pulse Pressure will be measured
Measured: Baseline, Post-Supplementation (7 days)
Change in HOMA2-IR, HOMA%S and HOMA%B
Homeostatic Model Assessment of Insulin Resistance, Sensitivity and Beta-cell function
Measured: Baseline, Post-Supplementation (7 days)
Change in Pulse Wave Analysis
Measured: 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
Beat-by-beat cardiac output, stroke volume, heart rate, total peripheral resistance, mean arterial pressure will be measured
Measured: 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
Measured: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
Change in Angiotensin Converting Enzyme Inhibition activity
Measured: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start15 May 2018
- Primary completion20 Sep 2018
- Study completion29 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hertfordshire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terun Desai, University of Hertfordshire
- Investigators
- Terun Desai, Principal investigator, University of Hertfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619941
- Sponsor's protocol ID
- LMS/PGR/UH/03319
- Status last verified
- Feb 2019
- First submitted
- 29 Jul 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32789528
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 7-day Continuous Montmorency Tart Cherry Juice Supplementation in Metabolic Syndrome Participants: a Pilot Study
- ClinicalTrials.gov ID
- NCT03619941
- Acronym / sponsor ID
- LMS/PGR/UH/03319
- Conditions
- Metabolic Syndrome, Insulin Resistance, Hypertension
- Keywords
- Montmorency Tart Cherry, Anthocyanins, Polyphenols, Metabolic Syndrome, Insulin Resistance, Hypertension, Lipid Profile, Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of HertfordshireUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 29 Sep 2018 (actual)
- First posted
- 8 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Montmorency Tart Cherry Juice | Experimental | Dietary Supplement: Montmorency Tart Cherry Juice |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 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 |
| PlaceboPlacebo drink attempted to match for total energy content, macronutrient content, appearance and taste of Montmorency tart cherry juice. | Dietary supplement | Placebo |
Primary outcome
Change in Fasting Insulin
Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
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)
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)
Change in Fasting Glucose
Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
6 secondary outcomes
Change in 24-hour Ambulatory Blood Pressure
Time frame: Baseline, Post-Supplementation (7 days)
Change in HOMA2-IR, HOMA%S and HOMA%B
Time frame: Baseline, Post-Supplementation (7 days)
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)
Change in Cardiac Haemodynamics
Time frame: 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
Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
Change in Angiotensin Converting Enzyme Inhibition activity
Time frame: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
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 19 Feb 2019.
- Derived from this study: PubMed 32789528Desai 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.
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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.
Terun Desai principal investigator
University of Hertfordshire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montmorency Tart Cherry Juice in people with Metabolic Syndrome and Insulin Resistance, run by University of Hertfordshire at 1 site in United Kingdom.
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 6 inclusion and 6 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 19 Feb 2019. 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: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)). 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 NCT03619941, which also lists 1 linked publication.
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 19 Feb 2019.