Impact of Powdered Tart Cherries on Recovery From Repeated Sprints

Inflammation Clinical Trial

— TCR  

Official title:

Impact of Powdered Tart Cherries on Recovery From Repeated Sprints in Trained Males and Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06122038
• Other study ID #: IRB-23-11
• Status: Completed
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: April 2024
• Source: Lindenwood University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate changes in force and power production, soreness, inflammation, and oxidative stress after repeated sprinting activity and powdered tart cherry ingestion in trained males and females.

Description:

The purpose of this study is to evaluate changes in force and power production, soreness, inflammation, and oxidative stress after repeated sprinting activity and powdered tart cherry ingestion in trained males and females. This study will utilize a randomized, double-blind, placebo group study design. Prior to any data collection, potential participants will be explained the protocol and then review and sign an IRB-approved consent form. Healthy male and female (n=40) participants who report regularly practicing or competing in high-intensity multi-modal resistance based exercise will complete the study protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy male and female (n=40) participants between the ages of 18 - 35 years of age will finish the study protocol. An even distribution of males (n=20) and females (n=20) is planned.

• Participating in some form of exercise at least four days per week with at least two days consisting of some form of high-intensity exercise for the past six months.

• Examples include regular gym attendance to complete resistance training, interval exercise, or participation in some form of organized physical activity involving high-speed running or other forms of high-intensity exercise.

• Have a body mass index (BMI) range of 18.0 - 30.0 kg/m2. Males with a body mass index greater than 30.0 kg/m2, but a body fat percentage less than 27.5% fat will be accepted into the study. Females with a body mass index greater than 30.0 kg/m2, but a body fat percentage less than 32.5% fat will be accepted into the study.

Exclusion Criteria:

• Participant has a positive medical history of heart disease/cardiovascular disease, uncontrolled hypertension (140/90 or greater mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease, or Type I or Type II diabetes.

• Participant has a positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within five years prior to screening visit.

• Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)

• Positive medical history for any neurological condition or neurological disease

• Currently smoke or have quit within the past six months

• Current daily use of aspirin, NSAIDS, naproxen sodium, COX-2 inhibitors, or any other over-the-counter or prescribed medication indicated for pain relief.

• Intake of any dietary supplement known or purported to impact muscle repair and recovery such as antioxidants, curcumin, turmeric, branched-chain amino acids, vitamin D, tart cherry, pomegranate, fish oils, or creatine monohydrate.

• Individuals who indicate they are actively involved in any form of a dietary program in the past 30 days to lose weight

• Participants who are lactating, pregnant or planning to become pregnant

• Have a known sensitivity or allergy to any of the study products

• Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data

• History of alcohol or substance abuse in the 12 months prior to screening

• Receipt or use of an investigational product in another research study within 28 days prior to baseline testing

Related Conditions & MeSH terms

• Inflammation
• Muscle Damage
• Myalgia
• Oxidative Stress
• Soreness, Muscle

Intervention

Dietary Supplement:
• Tart Cherry Extract Powder
Tart Cherry Extract Powder (NordicCherry, SpecNova, LLC). Dispensed during visit 1. Participants will consume 1 dose per day for 10 days.
• Placebo
Rice power placebo. Dispensed during visit 1. Participants will consume 1 dose per day for 10 days.

Locations

Country	Name	City	State
United States	Exercise and Performance Nutrition Laboratory	Saint Charles	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Lindenwood University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting Heart Rate	Resting heart rate at all study visits	10 days
Other	Resting Blood pressure	Resting Blood pressure at all study visits	10 days
Other	Reported Adverse Events	Self-Reported Adverse Events	10 days
Primary	Counter movement Jump Height	Jump height from counter movement jump	10 days
Primary	Counter movement jump peak propulsive force (N)	Peak propulsive force (N) from counter movement jump	10 days
Primary	Counter movement jump relative breaking force (N)	relative breaking force (N/kg) from counter movement jump	10 days
Primary	Isokinetic knee extension maximal voluntary contraction.	Peak isokinetic knee extension force (N) from a isokinetic knee extension exercise using a Biodex System 3	10 days
Primary	Isometric mid-thigh pull maximal voluntary contraction	Isometric maximal voluntary contraction peak force will be measured using an isometric mid-thigh pull assessment. Peak force production will be measured in Newtons.	10 days
Primary	Perceived recovery Visual Analog Scale	Perceived recovery Visual Analog Scale ranging from 0 (worst) to 100 (best)	10 days
Primary	Perceived soreness Visual Analog Scale	Perceived soreness Visual Analog Scale ranging from 0 (worst) to 100 (best)	10 days
Primary	Pain to Pressure threshold	Pain to Pressure threshold from algometry (higher = less sore). Minimum values are 0 N, maximum values are 110 N	10 days
Primary	Changes in Creatine Kinase concentrations	Changes in Creatine kinase concentrations following damaging exercise	10 days
Primary	Changes in Creatine Kinase-myocardial band concentrations	Changes in Creatine kinase-myocardial band concentrations following damaging exercise	10 days
Primary	Sprint time	Fastest and average sprint time during 15 30-meter sprint recorded using digitally timed timing gates	Baseline
Secondary	Peak power	Peak power during a wingate anaerobic test	10 days
Secondary	Changes in Protein carbonyls concentration	Protein carbonyls concentration changes	10 days
Secondary	Changes in 8-isoprostane concentration	8-isoprostane concentration changes	10 days
Secondary	Changes in testosterone-cortisol ratio	Testosterone-cortisol ratio changes	10 days
Secondary	Changes in TNF-alpha concentration	Changes in TNF-alpha concentration	10 days
Secondary	Changes in IL-6 concentration	Changes in IL-6 concentration	10 days
Secondary	Changes in IL-10 concentration	Changes in IL-10 concentration	10 days
Secondary	Desire to exercise visual analog scale	Desire to exercise visual analog scale (0 = not ready to train, 100 = very ready to train)	10 days
Secondary	Pittsburgh sleepiness Scale Score	Pittsburgh sleepiness Scale Score (lower scores indicate higher level of sleepiness)	10 days
Secondary	Changes in Uric Acid Concentrations	Changes in Uric Acid concentrations	10 days