Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

Sponsor

Ohio University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05614947

Collaborator

(none)

Enrollment

Location

Arms

20.8

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Dietary Supplement: Powdered tart cherry Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

Actual Study Start Date :

Apr 6, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tart cherry two capsules daily for 60 days	Dietary Supplement: Powdered tart cherry 500 mg freeze-dried tart cherry per capsule
Placebo Comparator: placebo two capsules daily for 60 days	Dietary Supplement: Placebo 500 mg colored cornstarch per capsule

Arm

Intervention/Treatment

Experimental: tart cherry

two capsules daily for 60 days

Dietary Supplement: Powdered tart cherry

500 mg freeze-dried tart cherry per capsule

Placebo Comparator: placebo

two capsules daily for 60 days

Dietary Supplement: Placebo

500 mg colored cornstarch per capsule

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio University Exercise Physiology Lab	Athens	Ohio	United States	45701

Sponsors and Collaborators

Ohio University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Angela Hillman, Assistant Professor of Exercise Physiology, Ohio University

ClinicalTrials.gov Identifier:

NCT05614947

Other Study ID Numbers:

20-F-16

First Posted:

Nov 14, 2022

Last Update Posted:

Nov 14, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metabolic Syndrome

Syndrome

Study Results

No Results Posted as of Nov 14, 2022