Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

NCT05614947 | Completed

• 1 other identifier: 20-F-16
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (7)

• Change in baseline systolic and diastolic blood pressure

  baseline, 60 days post supplmentation

• Change in fasting high-density lipoprotein (HDL) cholesterol

  baseline, 30 days post supplementation, 60 days post supplmentation

• Change in fasting triglyceride levels

  baseline, 30 days post supplementation, 60 days post supplmentation

• Change in fasting blood glucose level

  baseline, 30 days post supplementation, 60 days post supplmentation

• Change in waist circumference

  baseline, 60 days post supplmentation

• Change in body fat distribution

  baseline, 60 days post supplmentation

• Change in erythrocyte sedimentation rate

  baseline, 30 days post supplementation, 60 days post supplmentation

Study Arms (2)

tart cherry

EXPERIMENTAL

two capsules daily for 60 days

Dietary Supplement: Powdered tart cherry

placebo

PLACEBO COMPARATOR

two capsules daily for 60 days

Dietary Supplement: Placebo

Interventions

Powdered tart cherry DIETARY_SUPPLEMENT

500 mg freeze-dried tart cherry per capsule

tart cherry

Placebo DIETARY_SUPPLEMENT

500 mg colored cornstarch per capsule

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have been diagnosed with metabolic syndrome by a physician or meet the diagnostic criteria: Waist circumference greater than 40 inches (men) or greater than 35 inches (women), High blood pressure (greater than 130/80) or taking medication for high blood pressure, High triglycerides (greater than 150 mg/dL) or low HDL (less than 40 for men, less than 50 for women), High fasting blood glucose (100-126 mg/dL) or diagnosed as pre-diabetic
• Age 25-60

You may not qualify if:

• currently taking medication for glucose or lipid control, such as metformin and/or statin
• currently using anti-inflammatory medications \& have not used corticosteroids in the last two months
• diagnosed with or currently being treated for an inflammatory condition
• major organ system impairment (heart failure, renal failure, severe impairment of respiratory function)
• currently a smoker or quit less than 12 months ago

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University Exercise Physiology Lab

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Exercise Physiology

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: April 6, 2022
• Primary Completion: May 1, 2025
• Study Completion: July 25, 2025
• Last Updated: July 30, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)