- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555288
Sideritis Supplementation and Performance
The Effect of Sideritis as Supplement on Performance
Study Overview
Status
Conditions
Detailed Description
Significance of the Study:
There is currently no evidence supporting an improvement in athletic performance following the use of sideritis. Despite existing studies showing that the mechanism through which sideritis acts is almost identical to that of other supplements that have been found to enhance athletic performance, direct evidence for its effectiveness remains lacking.
Methodology:
Initially, the participants of the study will visit the laboratory in order to be informed about the exercise research protocol. During the first visit, the participants will perform a maximal oxygen uptake (VO₂max) test on a treadmill using the RAMP protocol. In this specific method for determining maximal oxygen uptake, the treadmill speed will increase by 1 km/h every minute. Thus, the participants will reach exhaustion gradually.
The participants will visit the laboratory two more times in order to perform the exercise protocols. One hour before each session, each participant will receive a dietary supplement, which will contain either 950 mg of sideritis or a specific dosage of a neutral substance (placebo). The selection of supplements will be random, as the study will be conducted using a double-blind design. This means that neither the participants nor the researcher will know which type of supplement has been consumed prior to the exercise protocol. The exercise protocol will consist of 60 minutes of treadmill running at an intensity of 70-75% of VO₂max, which has been individually determined for each participant based on the prior VO₂max test. During these 60 minutes, a gas exchange mask will be used to determine that participants are running at the specified intensity. After the 60 minutes, participants will wear the mask again and will run at a higher intensity (90-95% VO₂max) until exhaustion (Time to Exhaustion). Before each exercise protocol, and at 15, 30, 45, and 60 minutes during exercise, as well as immediately after completion, capillary blood samples will be collected to assess lactate and glucose levels. Additionally, body composition measurements will be conducted using the BIA method. Participants' dietary intake will also be recorded for the day prior to the VO₂max test, as well as for the days preceding the exercise protocol sessions. This recording will be conducted in order to determine whether any participant has consumed sideritis through their diet prior to the protocol.
Statistical Analysis
A 2-way repeated measures ANOVA will be performed. The statistical program SPSS 26 will be used.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Athanasios Jamurtas Z Jamurtas, Professor
- Phone Number: Ext. +30 24310 47054
- Email: ajamurt@uth.gr
Study Locations
-
-
Thessaly
-
Trikala, Thessaly, Greece, 42150
- Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy Individuals aged 18-40 years
Exclusion Criteria:
- Musculoskeletal Injury
- Dietary supplements
- Medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sideritis Scardica (SidTea+) extract
Sideritis Scardica (SidTea+) extract will be administered to participants in this arm.
|
950 mg of Sideritis Scardica (SidTea+) extract one hour pre-exercise during exercise day
|
|
Placebo Comparator: Placebo Supplementation
Placebo will be administered to participants in this arm.
|
950 mg of placebo one hour pre-exercise during exercise day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Blood lactate
Time Frame: Change from baseline to 15, 30, 45, 60 minutes during exercise and immediately post-exercise
|
Blood lactate concentration will be estimated using an analyzer.
|
Change from baseline to 15, 30, 45, 60 minutes during exercise and immediately post-exercise
|
|
Change in mean respiratory quotient during exercise
Time Frame: Mean respiratory quotient will be measured during 60 minute of exercise
|
The mean respiratory quotient during exercise will be measured using a gas analyzer
|
Mean respiratory quotient will be measured during 60 minute of exercise
|
|
Change in mean oxygen consumption during exercise
Time Frame: Mean oxygen consumption will be measured during 60 minute of exercise
|
Mean oxygen consumption during exercise will be measured using a gas analyzer
|
Mean oxygen consumption will be measured during 60 minute of exercise
|
|
Change in mean Heart rate during exercise
Time Frame: Mean heart rate will be measured during 60 minute of exercise
|
Mean heart rate during exercise will be measured using a heart rate monitor
|
Mean heart rate will be measured during 60 minute of exercise
|
|
Change in time to exhaustion
Time Frame: The time to exhaustion will be measured immediately after 60 minute of exercise
|
Time to exhaustion will be estimated using an electronic timer
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The time to exhaustion will be measured immediately after 60 minute of exercise
|
|
Change in Glucose concentration
Time Frame: Change from baseline to 15, 30, 45, 60 minutes during exercise and immediately post-exercise
|
Glucose concentration will be estimated using an analyzer.
|
Change from baseline to 15, 30, 45, 60 minutes during exercise and immediately post-exercise
|
|
Change in heart rate
Time Frame: Change from baseline to 15, 30, 45, 60 minutes during exercise and immediately post-exercise
|
Heart rate will be estimated using monitor units.
|
Change from baseline to 15, 30, 45, 60 minutes during exercise and immediately post-exercise
|
|
Change in oxygen consumption
Time Frame: Change from baseline to 15, 30, 45, 60 minutes during exercise and immediately post-exercise
|
Oxygen consumption will be estimated using gas analyzer
|
Change from baseline to 15, 30, 45, 60 minutes during exercise and immediately post-exercise
|
|
Change in respiratory quotient
Time Frame: Change from baseline to 15, 30, 45, 60 minutes during exercise and immediately post-exercise
|
Respiratory quotient will be estimated using gas analyzer
|
Change from baseline to 15, 30, 45, 60 minutes during exercise and immediately post-exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body weight
Time Frame: Baseline
|
Body weight will be estimated using beam balance scale
|
Baseline
|
|
Body fat (%)
Time Frame: Baseline
|
Body fat will be measured by bioelectrical impedance analysis
|
Baseline
|
|
Resting Heart Rate
Time Frame: Baseline
|
Resting heart rate will be measured using a heart rate sensor
|
Baseline
|
|
Diastolic and systolic blood pressure
Time Frame: Baseline
|
Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer
|
Baseline
|
|
Maximal oxygen consumption (VO2max)
Time Frame: Baseline
|
VO2max will be measured using an automated open-circuit spirometer
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Athanasios Z Jamurtas, Professor, University of Thessaly
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- UTH_DPESS_SID_PER
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
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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