Sideritis Supplementation and Performance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 950 mg of Sideritis Scardica (SidTea+) extract one hour pre-exercise, 950 mg of placebo one hour pre-exercise.
- Who it may be relevant to
- Registry conditions: Athletic Performance. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Sideritis as Supplement on Performance
Overview
The purpose of this study is to examine the effect of sideritis consumption on physiological and performance indicators in adult subjects and compare it with the control trial.
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.
Interventions
- Dietary supplement 950 mg of Sideritis Scardica (SidTea+) extract one hour pre-exercise
950 mg of Sideritis Scardica (SidTea+) extract one hour pre-exercise during exercise day - Dietary supplement 950 mg of placebo one hour pre-exercise
950 mg of placebo one hour pre-exercise during exercise day
Primary outcome measures
- Change in Blood lactate [Time frame: 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]
- Change in mean oxygen consumption during exercise [Time frame: 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]
- Change in time to exhaustion [Time frame: 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]
- Change in heart rate [Time frame: 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]
- Change in respiratory quotient [Time frame: Change from baseline to 15, 30, 45, 60 minutes during exercise and immediately post-exercise]
Secondary outcome measures (5)
- Body weight [Time frame: Baseline]
- Body fat (%) [Time frame: Baseline]
- Resting Heart Rate [Time frame: Baseline]
- Diastolic and systolic blood pressure [Time frame: Baseline]
- Maximal oxygen consumption (VO2max) [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Healthy Individuals aged 18-40 years
Exclusion criteria
- Musculoskeletal Injury
- Dietary supplements
- Medication
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
Greece · 1 center
- Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Educati — Trikala
Publications
- Papanikolaou K, Kouloridas K, Rosvoglou A, Gatsas A, Georgakouli K, Deli CK, Draganidis D, Argyropoulou A, Michailidis D, Fatouros IG, Jamurtas AZ. Characterization of the Sideritis scardica Extract SidTea+TM and Its Effect on Physiological Profile, Metabolic Health and Redox Biomarkers in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Study. Molecules. 2024 Mar 1;29(5):1113. doi: PMID 38474625
Identifiers
NCT: NCT07555288 · UTH_DPESS_SID_PER