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Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Powdered tart cherry
Placebo
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Ohio University Exercise Physiology LabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tart cherry

placebo

Arm Description

two capsules daily for 60 days

two capsules daily for 60 days

Outcomes

Primary Outcome Measures

Change in baseline systolic and diastolic blood pressure
Change in fasting high-density lipoprotein (HDL) cholesterol
Change in fasting triglyceride levels
Change in fasting blood glucose level
Change in waist circumference
Change in body fat distribution
Change in erythrocyte sedimentation rate

Secondary Outcome Measures

Full Information

First Posted
November 7, 2022
Last Updated
November 7, 2022
Sponsor
Ohio University
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1. Study Identification

Unique Protocol Identification Number
NCT05614947
Brief Title
Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome
Official Title
Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tart cherry
Arm Type
Experimental
Arm Description
two capsules daily for 60 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
two capsules daily for 60 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Powdered tart cherry
Intervention Description
500 mg freeze-dried tart cherry per capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
500 mg colored cornstarch per capsule
Primary Outcome Measure Information:
Title
Change in baseline systolic and diastolic blood pressure
Time Frame
baseline, 60 days post supplmentation
Title
Change in fasting high-density lipoprotein (HDL) cholesterol
Time Frame
baseline, 30 days post supplementation, 60 days post supplmentation
Title
Change in fasting triglyceride levels
Time Frame
baseline, 30 days post supplementation, 60 days post supplmentation
Title
Change in fasting blood glucose level
Time Frame
baseline, 30 days post supplementation, 60 days post supplmentation
Title
Change in waist circumference
Time Frame
baseline, 60 days post supplmentation
Title
Change in body fat distribution
Time Frame
baseline, 60 days post supplmentation
Title
Change in erythrocyte sedimentation rate
Time Frame
baseline, 30 days post supplementation, 60 days post supplmentation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ohio University Exercise Physiology Lab
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Hillman, PhD
Phone
740-593-0153
Email
hillman@ohio.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

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