Diet, HealthyNCT06184061
Acute Effects of Herbal Dietary Supplements on Aerobic Performance
A study testing Herbal Supplement in people with Diet, Healthy, run by Eastern Mediterranean University at 1 site in Cyprus.
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… Read more about this study
- Who is it for?
- Ages 19 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Herbal Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCyprus
- Study dates
- 30 Nov 2023to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Having a known food allergy
- Using any supplement
- Being a professional athlete
- Drinking alcohol regularly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Assessment of the Acute Effects of Herbal Dietary Supplements on Aerobic Performance in Recreational Athletes
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.
Read the 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.
- Conditions
- Diet, Healthy
- Being tested
- Herbal Supplement
- Keywords
- Athlete Performance, Nutritional Supplement, Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal SupplementCombination product
Herbal supplement will be the mixture of strawberry, black mulberry, blueberry, raspberry, ginseng, ashwagandha, honey, water
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Placebo will be given to this group (100ml, contain same carbohydrate amount as herbal supplement) |
| Interventional Group | Active comparator | Herbal Supplement will be given to this group (100ml, Herbal Supplement) Receives: Combination Product: Herbal Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: Up to 1 week
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.
Measured: Up to 1 week
Secondary outcomes (2)
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
Measured: 1 minutes
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
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start30 Nov 2023
- Primary completion19 Jan 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezire İnce, Eastern Mediterranean University
- Investigators
- Nezire Ince, Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184061
- Sponsor's protocol ID
- ETK00-2023-0207
- Status last verified
- Aug 2025
- First submitted
- 29 Nov 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Acute Effects of Herbal Dietary Supplements on Aerobic Performance in Recreational Athletes
- ClinicalTrials.gov ID
- NCT06184061
- Acronym / sponsor ID
- ETK00-2023-0207
- Conditions
- Diet, Healthy
- Keywords
- Athlete Performance, Nutritional Supplement, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Placebo will be given to this group (100ml, contain same carbohydrate amount as herbal supplement) |
| Interventional Group | Active comparator | Combination Product: Herbal SupplementHerbal Supplement will be given to this group (100ml, Herbal Supplement) |
Who may qualify
- Ages
- 19 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Having a known food allergy
- Using any supplement
- Being a professional athlete
- Drinking alcohol regularly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal SupplementHerbal supplement will be the mixture of strawberry, black mulberry, blueberry, raspberry, ginseng, ashwagandha, honey, water | Combination product | Interventional Group |
Primary outcome
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"
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.
2 secondary outcomes
Change between end-test heart rate and heart rate 1 minute post Yo-Yo intermittent recovery test (level 1)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nezire Ince study director
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal Supplement in people with Diet, Healthy, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vo2 Max (time frame: Up to 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.