Tart Cherry Supplement for Metabolic Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio University
Must not be taking: Glucose control, Statins, Anti-inflammatories
Disqualifiers: Inflammatory conditions, Organ failure, Smoking, others
Approved in 1 Jurisdiction
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.
12345Is 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.
12346How 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.
12347Eligibility 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.
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: tart cherryExperimental Treatment1 Intervention
two capsules daily for 60 days
Group II: placeboPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ohio University Exercise Physiology LabAthens, OH
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Who Is Running the Clinical Trial?
Ohio UniversityLead Sponsor
References
Effect of Tart Cherry Concentrate on Endurance Exercise Performance: A Meta-analysis. [2021]Objective: Tart cherry concentrate has been shown to improve muscle function, and reduce muscle damage, oxidative stress/inflammation, and muscle soreness in athletes; however, evidence for acute endurance performance benefits is scarce. The purpose of this review was to evaluate the effect of tart cherry juice on endurance exercise performance with a meta-analysis.Method: Data sources included Medline, Embase, Web of Science, and Google Scholar. Eligibility criteria were randomized controlled trials with endurance exercise performance tests. Participants were healthy individuals. Interventions included tart cherry supplementation and placebo ingested before, and/or on the day of exercise. Ten studies were included (totaling 127 males and 20 females). Standardized mean differences (SMD) with 95% confidence intervals were calculated for each study and pooled effects were assessed.Results: Tart cherry concentrate in juice or powdered form, ingested for 7 days to 1.5 hours before exercise performance testing significantly improved endurance exercise performance (SMD: 0.36; 95% CI: 0.07 to 0.64; p = 0.01; I2 = 0%) upon pooling of the ten studies.Conclusions: Tart cherry concentrate has a significant benefit for endurance exercise performance. Key teaching pointsTart cherry concentrate has a significant benefit for endurance exercise performance.Tart cherry concentrate may enhance endurance exercise performance via its low glycemic index, anti-inflammatory and anti-oxidative capacity, and blood flow enhancing effects.
Effects of short-term continuous Montmorency tart cherry juice supplementation in participants with metabolic syndrome. [2022]Metabolic Syndrome (MetS) augments the incidence of cardiovascular disease by two-fold and type II diabetes mellitus by five-fold. Montmorency tart cherries are rich in phytochemicals shown to improve biomarkers related to cardio-metabolic health in humans. This study aimed to examine cardio-metabolic responses after 7-days Montmorency tart cherry juice (MTCJ) supplementation and also acute on short-term supplementation responses to a single bolus, in humans with MetS.
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]Tart Montmorency cherries (MC) have been shown to be rich in anthocyanins and other phytochemicals known to have anti-inflammatory properties and influence pathways that might improve cardiometabolic health. However, there is limited evidence for the longer-term use of tart cherries on these indices. The aim of the current study was to investigate the influence of MC concentrate on cardiometabolic health indices following a 3-month supplementation period.
Effects of Montmorency Tart Cherry Juice Consumption on Cardiometabolic Biomarkers in Adults with Metabolic Syndrome: A Randomized Controlled Pilot Trial. [2021]Greater than one-third of adults in the United States have metabolic syndrome (MetS), a cluster of risk factors highly associated with the development of cardiovascular diseases. Premature vascular dysfunction in MetS may lead to accelerated age-related atherogenesis and arterial stiffening, thereby increasing cardiovascular risk. Montmorency tart cherries (Prunus cerasus L.) are rich in bioactive compounds, such as anthocyanins, known to exert cardiovascular protective effects. Previous research suggests that tart cherry juice consumption may improve cardiovascular health. The objective of this study was to evaluate the effects of daily consumption of tart cherry juice on hemodynamics, arterial stiffness, and blood biomarkers of cardiovascular and metabolic health in men and women with MetS. In a randomized, single-blind, placebo-controlled, parallel-arm pilot clinical trial, 19 men and women 20 to 60 years of age with MetS consumed 240 mL of tart cherry juice (Tart Cherry; n = 5 males, 4 females) or an isocaloric placebo-control drink (Control; n = 5 males, 5 females) twice daily for 12 weeks. Arterial stiffness (pulse wave velocity), brachial and aortic blood pressures, wave reflection (augmentation index), and blood biomarkers of cardiovascular and metabolic health were assessed at baseline and 6 and 12 weeks. Oxidized low-density lipoprotein and soluble vascular cell adhesion molecule-1 were significantly lower (P = .047 and P = .036, respectively) in Tart Cherry than Control at 12 weeks, but were not significantly lower than baseline values. There was a trend for total cholesterol to be lower (P = .08) in Tart Cherry than Control at 12 weeks. No significant changes were observed in hemodynamics, arterial stiffness, or other blood biomarkers assessed. These results suggest that daily tart cherry consumption may attenuate processes involved in accelerated atherogenesis without affecting hemodynamics or arterial stiffness parameters in this population. The pilot nature of this study warrants interpreting these findings with caution, and future clinical trials with a larger sample size are needed to confirm these findings.
Impact of tart cherry juice on systolic blood pressure and low-density lipoprotein cholesterol in older adults: a randomized controlled trial. [2018]Hypertension and dyslipidemia are major risk factors for cardiovascular disease (CVD). Common treatments for high blood pressure (BP) and dyslipidemia include medications, but there is question as to whether natural sources may be adequate to reduce CVD risk factors. We examined the effects of tart cherry juice on lipid profiles, BP, glucose, insulin, and homeostatic model assessment-insulin resistance (HOMA-IR) in older adults. In this randomized-controlled clinical trial, 17 men and 20 women between the ages of 65-80 years were randomly assigned to consume 480 ml of tart cherry juice or control drink daily for 12 weeks. Control beverages were matched for energy and sugar content. Outcome variables were assessed at baseline and after 12 weeks of tart cherry juice or control drink. Systolic BP and low-density lipoprotein cholesterol (LDL) exhibited treatment × time interaction effects. At the end of the study, participants in the tart cherry group had lower levels of LDL cholesterol (difference of -20.6 with P = 0.001) and total cholesterol (difference of -19.11 with P = 0.01), and higher levels of glucose (difference of 7.94 with P = 0.001), triglycerides (difference of 6.66 with P = 0.01) and BMI (difference of 1.06 with P = 0.02) than in the control group. Neither tart cherry juice nor control significantly altered body weight, high-density lipoprotein cholesterol, diastolic BP, insulin and HOMA-IR. Our findings show that tart cherry juice can lower the levels of systolic BP and LDL cholesterol. However, larger and longer follow-up studies are needed to further assess cardio-protective effects of tart cherry juice.
Recovery facilitation with Montmorency cherries following high-intensity, metabolically challenging exercise. [2022]The impact of Montmorency tart cherry (Prunus cerasus L.) concentrate (MC) on physiological indices and functional performance was examined following a bout of high-intensity stochastic cycling. Trained cyclists (n = 16) were equally divided into 2 groups (MC or isoenergetic placebo (PLA)) and consumed 30 mL of supplement, twice per day for 8 consecutive days. On the fifth day of supplementation, participants completed a 109-min cycling trial designed to replicate road race demands. Functional performance (maximum voluntary isometric contraction (MVIC), cycling efficiency, 6-s peak cycling power) and delayed onset muscle soreness were assessed at baseline, 24, 48, and 72 h post-trial. Blood samples collected at baseline, immediately pre- and post-trial, and at 1, 3, 5, 24, 48, and 72 h post-trial were analysed for indices of inflammation (interleukin (IL)-1β, IL-6, IL-8, tumor necrosis factor alpha, high-sensitivity C-reactive protein (hsCRP)), oxidative stress (lipid hydroperoxides), and muscle damage (creatine kinase). MVIC (P
Efficacy and safety of tart cherry supplementary citrate mixture on gout patients: a prospective, randomized, controlled study. [2023]Low urine pH, which may be mediated by metabolic syndrome (MetS), is common in gout. Tart cherries are shown to improve MetS symptoms and possess anti-inflammatory properties. However, the efficacy of tart cherry supplements on urine pH has yet to be studied.