- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06184061
Acute Effects of Herbal Dietary Supplements on Aerobic Performance
An Assessment of the Acute Effects of Herbal Dietary Supplements on Aerobic Performance in Recreational Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Famagusta, Cyprus, 99520
- Nezire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Placebo will be given to this group (100ml, contain same carbohydrate amount as herbal supplement)
|
|
|
Active Comparator: Interventional Group
Herbal Supplement will be given to this group (100ml, Herbal Supplement)
|
Herbal supplement will be the mixture of strawberry, black mulberry, blueberry, raspberry, ginseng, ashwagandha, honey, water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vo2 Max
Time Frame: Up to 1 week
|
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
|
|
Total distance covered in Yo-Yo intermittent recovery test (level 1)
Time Frame: Up to 1 week
|
Once the test is completed, total distance covered by participants during the test will be recorded in meters.
|
Up to 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change between end-test heart rate and heart rate 1 minute post Yo-Yo intermittent recovery test (level 1)
Time Frame: 1 minutes
|
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
|
|
Change between end-test heart rate and heart rate 2 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 2 minutes
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI
Time Frame: Up to 2 weeks
|
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
|
|
Waist Circumference
Time Frame: Up to 2 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nezire Ince, Eastern Mediterranean University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ETK00-2023-0207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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