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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06184061
Other study ID # ETK00-2023-0207
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 30, 2023
Est. completion date January 19, 2024

Study information

Verified date November 2023
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Positive effects of herbal supplements such as red berries, ginseng, ashwagandha on athletic performance have been reported. The aim of this study was to evaluate the acute effects of a herbal dietary supplement prepared from a mixture of red berries, ginseng and ashwagandha on aerobic performance of recreational athletes.


Description:

In the beginning of the study anthropometric measurements (weight (kg), height (cm), BMI, waist circumference (cm), body fat percentage, lean body mass, skeletal muscle mass) will be taken from the participants who accepted to participate in the study. During the study, participants will be restricted from consuming alcohol, caffeine, red fruit, ginseng and ashwagandha. First, Yoyo Intermittent Recovery Level 1 performance test (The Yo-Yo test is a maximal aerobic endurance fitness test, involving running between markers placed 20 meters apart, at increasing speeds, until exhaustion) will be done to all participants In this step, participants will not drink anything. Then there will be a 2-week break. At the end of the 3-week break, the participants will be divided into two groups by block randomization method and one group will receive a herbal nutritional supplement mixture (100 ml 30 minutes before training). The other group will drink a placebo prepared with the same texture and consistency as our main mixture, containing an equal amount of carbohydrates (100 ml 30 minutes before training). Then the same performance test will be repeated. At the end of the test also 1 and 2 minutes after end of the test, the participants' heart rate measurement will be taken with a finger-type pulse oximeter and recorded . At the end of the test, perceived exertion levels will be questioned using the Borg scale.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date January 19, 2024
Est. primary completion date January 19, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 23 Years
Eligibility Inclusion Criteria: - Being a student in the Exercise and Sports sciences department - Not using any supplement - Not being in a period that will affect sleep patterns (midterm/finals week, holiday, etc.) - Doing regular exercise Exclusion Criteria: - Having a known food allergy - Using any supplement - Being a professional athlete - Drinking alcohol regularly

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Herbal Supplement
Herbal supplement will be the mixture of strawberry, black mulberry, blueberry, raspberry, ginseng, ashwagandha, honey, water

Locations

Country Name City State
Cyprus Nezire Famagusta

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Other BMI BMI will be calculated. For the calculation of BMI; weight (kg), height (m) will be measured and formulated as follow (weight (kg) / (height (m))2 Up to 2 weeks
Other Waist Circumference Waist circumference of the participants will be measured by placing the measuring tape around your middle at a point halfway between the bottom of your ribs and the top of your hips (just above the belly button) and recorded Up to 2 weeks
Primary Vo2 Max Once the test is completed, participants' Vo2 max values will be calculated using the formula "Vo2 max= Distance covered x 0.0084 + 36.4" Up to 1 week
Primary Total distance covered in Yo-Yo intermittent recovery test (level 1) Once the test is completed, total distance covered by participants during the test will be recorded in meters. Up to 1 week
Secondary Change between end-test heart rate and heart rate 1 minute post Yo-Yo intermittent recovery test (level 1) Volunteers' heart rate was taken immediately after the Yo-Yo intermittent recovery test (level 1) and 1 minute post test. Heart rates were detected by using finger tip pulse oximeter 1 minutes
Secondary Change between end-test heart rate and heart rate 2 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' heart rate was taken immediately after the Yo-Yo intermittent recovery test (level 1) and 2 minute post test. Heart rates were detected by using finger tip pulse oximeter 2 minutes
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