Tart Cherry Supplement for Metabolic Syndrome

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ohio University

Must not be taking: Glucose control, Statins, Anti-inflammatories

Disqualifiers: Inflammatory conditions, Organ failure, Smoking, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Metabolic syndrome (MetSyn) is a growing health concern, with up to 25% of the worlds population having the syndrome. MetSyn is a primary risk factor for cardiovascular disease and type II diabetes development, and is independently associated with all-cause mortality, making it an important disease target. The primary treatment for MetSyn is exercise and weight loss, along with medically necessary treatment. Exercise, along with dietary changes such as increased fiber and polyphenol intake can positively impact many of the metabolic abnormalities seen with MetSyn. For example, polyphenols have been shown to decrease lipid concentration and improved glucose clearance as well as decreased oxidative stress and inflammation. Powdered tart cherry capsules, which contain the skin of the fruit, provides polysaccharides (fiber) that would likely act as a substrate for gut bacteria degradation, providing energy substrates and barrier integrity to the colonocytes and increasing the bioavailability of the polyphenols to other cells in the body. However there have been no long-term investigations into the use of powdered tart cherry supplements in MetSyn, therefore we aim to determine if 60 days tart cherry supplementation modify criteria for MetSyn in currently diagnosed individuals including body mass, waist circumference, blood pressure, blood lipid levels and blood glucose control.

Will I have to stop taking my current medications?

If you are currently taking medication for glucose or lipid control, such as metformin or statins, you cannot participate in this trial. The protocol does not specify about other medications, but it seems you may need to stop certain medications to be eligible.

What data supports the effectiveness of the tart cherry supplement treatment for metabolic syndrome?

Research suggests that Montmorency tart cherry juice, rich in beneficial compounds, may help improve heart and metabolic health markers in people with metabolic syndrome. Studies have shown it can lower bad cholesterol and blood pressure, which are important for heart health. ^{1 2 3 4 5}

Is tart cherry supplementation safe for humans?

Research on tart cherry supplements, including Montmorency tart cherry juice and concentrate, suggests they are generally safe for human consumption. Studies have not reported significant adverse effects, and tart cherries are rich in beneficial compounds like anthocyanins, which have anti-inflammatory properties. ^{1 2 3 4 6}

How does tart cherry powder differ from other treatments for metabolic syndrome?

Tart cherry powder is unique because it is rich in bioactive compounds like anthocyanins, which have cardiovascular protective effects and may improve biomarkers related to cardio-metabolic health. Unlike some other treatments, it is a natural supplement that can be consumed as a juice or powder, offering potential benefits without the use of synthetic drugs. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for adults aged 25-60 with metabolic syndrome, characterized by a large waistline, high blood pressure or medication use for it, abnormal cholesterol levels, and elevated fasting blood sugar. Participants should not have inflammatory conditions, be on anti-inflammatory meds or steroids recently, have major organ failure, smoke currently or quit within the last year.

Inclusion Criteria

I have been diagnosed with metabolic syndrome or meet its criteria.

I am between 25 and 60 years old.

Exclusion Criteria

I have been diagnosed with or am currently being treated for an inflammatory condition.

You are currently smoking or stopped smoking less than a year ago.

I am currently on medication for blood sugar or cholesterol.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two capsules daily of either tart cherry or placebo for 60 days

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Powdered Tart Cherry

Trial Overview The study tests if powdered tart cherry supplements can improve metabolic syndrome over 60 days. It compares the effects of these supplements to a placebo (a substance with no therapeutic effect) on body mass, waist size, blood pressure, lipid levels and glucose control in participants.

Participant Groups

Group I: tart cherry Experimental Treatment 1 Intervention

two capsules daily for 60 days

Group II: placebo Placebo Group 1 Intervention

two capsules daily for 60 days

Powdered Tart Cherry is already approved in United States for the following indications:

Approved in United States as Tart Cherry Powder for:

• Supports healthy joint function
• Supports healthy cardiovascular system
• May help manage metabolic syndrome

Who Is Running the Clinical Trial?

Ohio University

Lead Sponsor

Trials

73

Recruited

17,800+

Findings from Research

A meta-analysis of 10 randomized controlled trials involving 147 participants showed that tart cherry concentrate significantly improves endurance exercise performance when consumed 7 days to 1.5 hours before exercise, with a standardized mean difference of 0.36.

The benefits of tart cherry concentrate for endurance performance may be attributed to its low glycemic index, anti-inflammatory and antioxidant properties, and its ability to enhance blood flow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Tart Cherry Concentrate on Endurance Exercise Performance: A Meta-analysis. Gao, R., Chilibeck, PD.[2021]

In a study involving 12 participants with Metabolic Syndrome, 7 days of Montmorency tart cherry juice (MTCJ) supplementation significantly reduced 24-hour blood pressure and improved key metabolic markers such as fasting glucose and cholesterol levels compared to a placebo.

The findings suggest that MTCJ may play a beneficial role in improving cardio-metabolic health, highlighting its potential as a preventive measure against cardiovascular disease and type II diabetes in individuals with MetS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of short-term continuous Montmorency tart cherry juice supplementation in participants with metabolic syndrome. Desai, T., Roberts, M., Bottoms, L.[2022]

A 3-month study involving 50 middle-aged adults found that tart Montmorency cherry concentrate did not significantly affect vascular function or metabolic health indices compared to a placebo.

Despite the lack of efficacy in improving cardiometabolic health, the tart cherry concentrate was safe and well-tolerated, indicating it does not have harmful effects on these health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Tart Cherry (Prunus cerasus, cv Montmorency) Concentrate Supplementation for 3 Months on Cardiometabolic Risk Factors in Middle-Aged Adults: A Randomised, Placebo-Controlled Trial. Kimble, R., Keane, KM., Lodge, JK., et al.[2023]

In a pilot study involving 19 adults with metabolic syndrome, daily consumption of 240 mL of tart cherry juice for 12 weeks led to significant reductions in oxidized low-density lipoprotein and soluble vascular cell adhesion molecule-1, suggesting potential cardiovascular benefits.

Despite these positive changes in specific blood biomarkers, the study found no significant improvements in overall hemodynamics or arterial stiffness, indicating that while tart cherry juice may help with certain cardiovascular risk factors, its effects on blood pressure and arterial health need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Montmorency Tart Cherry Juice Consumption on Cardiometabolic Biomarkers in Adults with Metabolic Syndrome: A Randomized Controlled Pilot Trial. Johnson, SA., Navaei, N., Pourafshar, S., et al.[2021]

In a 12-week randomized-controlled trial with 37 older adults, tart cherry juice significantly reduced systolic blood pressure and low-density lipoprotein (LDL) cholesterol levels, indicating potential cardiovascular benefits.

While tart cherry juice improved certain lipid profiles, it also led to increases in glucose, triglycerides, and body mass index (BMI), suggesting that further research is needed to fully understand its effects on cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of tart cherry juice on systolic blood pressure and low-density lipoprotein cholesterol in older adults: a randomized controlled trial. [2018]

Montmorency tart cherry concentrate (MC) improved recovery in trained cyclists by maintaining muscle strength (MVIC) and enhancing cycling efficiency after high-intensity exercise, compared to a placebo.

MC also significantly reduced markers of inflammation (IL-6 and hsCRP) following strenuous cycling, suggesting it can help accelerate recovery and mitigate exercise-induced inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery facilitation with Montmorency cherries following high-intensity, metabolically challenging exercise. Bell, PG., Walshe, IH., Davison, GW., et al.[2022]

In a study involving 282 men with gout, the tart cherry supplementary citrate (TaCCi) mixture showed similar effectiveness in increasing urine pH and lowering serum urate levels compared to sodium bicarbonate and citrate mixture, indicating it is a viable option for gout management.

The TaCCi mixture led to greater reductions in urine albumin/creatinine ratio and C-reactive protein levels, suggesting additional benefits for kidney protection and inflammation reduction in gout patients starting urate-lowering therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tart cherry supplementary citrate mixture on gout patients: a prospective, randomized, controlled study. Wang, C., Sun, W., Dalbeth, N., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Tart Cherry Concentrate on Endurance Exercise Performance: A Meta-analysis. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of short-term continuous Montmorency tart cherry juice supplementation in participants with metabolic syndrome. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Influence of Tart Cherry (Prunus cerasus, cv Montmorency) Concentrate Supplementation for 3 Months on Cardiometabolic Risk Factors in Middle-Aged Adults: A Randomised, Placebo-Controlled Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Montmorency Tart Cherry Juice Consumption on Cardiometabolic Biomarkers in Adults with Metabolic Syndrome: A Randomized Controlled Pilot Trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Impact of tart cherry juice on systolic blood pressure and low-density lipoprotein cholesterol in older adults: a randomized controlled trial. [2018]

6. Canada pubmed.ncbi.nlm.nih.gov

Recovery facilitation with Montmorency cherries following high-intensity, metabolically challenging exercise. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tart cherry supplementary citrate mixture on gout patients: a prospective, randomized, controlled study. [2023]