Clinical trial NCT06122038: Impact of Powdered Tart Cherries on Recovery From Repeated Sprints
Official title: Impact of Powdered Tart Cherries on Recovery From Repeated Sprints in Trained Males and Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Oxidative Stress
Soreness, Muscle
Muscle Damage
Keywords: Tart Cherry
Inflammation
Muscle Soreness
Muscle Damage
Lead sponsor: Lindenwood University
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will utilize a randomized, double-blind, placebo group study design
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Counter movement Jump Height
timeFrame: 10 days
measure: Counter movement jump peak propulsive force (N)
timeFrame: 10 days
measure: Counter movement jump relative breaking force (N)
timeFrame: 10 days
measure: Isokinetic knee extension maximal voluntary contraction.
timeFrame: 10 days
measure: Isometric mid-thigh pull maximal voluntary contraction
timeFrame: 10 days
measure: Perceived recovery Visual Analog Scale
timeFrame: 10 days
measure: Perceived soreness Visual Analog Scale
timeFrame: 10 days
measure: Pain to Pressure threshold
timeFrame: 10 days
measure: Changes in Creatine Kinase concentrations
timeFrame: 10 days
measure: Changes in Creatine Kinase-myocardial band concentrations
timeFrame: 10 days
measure: Sprint time
timeFrame: Baseline
Secondary outcomes:
measure: Peak power
timeFrame: 10 days
measure: Changes in Protein carbonyls concentration
timeFrame: 10 days
measure: Changes in 8-isoprostane concentration
timeFrame: 10 days
measure: Changes in testosterone-cortisol ratio
timeFrame: 10 days
measure: Changes in TNF-alpha concentration
timeFrame: 10 days
measure: Changes in IL-6 concentration
timeFrame: 10 days
measure: Changes in IL-10 concentration
timeFrame: 10 days
measure: Desire to exercise visual analog scale
timeFrame: 10 days
measure: Pittsburgh sleepiness Scale Score
timeFrame: 10 days
measure: Changes in Uric Acid Concentrations
timeFrame: 10 days
Other outcomes:
measure: Resting Heart Rate
timeFrame: 10 days
measure: Resting Blood pressure
timeFrame: 10 days
measure: Reported Adverse Events
timeFrame: 10 days
Locations:
city: Saint Charles
country: United States
facility: Exercise and Performance Nutrition Laboratory
state: Missouri
Study officials:
affiliation: Lindenwood University
name: Chad M Kerksick, PhD
role: PRINCIPAL_INVESTIGATOR
References: