Healthy AthletesNCT07280520
The Role of Luteolin Supplementation in Cellular Metabolism of Myocytes and Fat Cells, Physical Performance, and Body Composition in Athletes.
A study testing luteolin in people with Healthy Athletes, run by University of Jordan at 1 site in Jordan.
Trial summary
A clinical trial is to determine whether Luteolin supplementation can enhance cellular metabolism and improve physical performance in apparently healthy Jordanian male athletes aged 18-35 with continuous training experience. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Athletes
- What is being tested?
- luteolin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 1 Nov 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender and Age: Male volunteers aged 18 to 35 years old.
- Athletic Status: Currently training male athletes with continuous sports training experience in any field (e.g., endurance, team sports, strength training).
- Health Status: Apparently healthy, with no known chronic diseases or metabolic disorders that could interfere with lipid or muscle metabolism (e.g., diabetes, liver disease, kidney disease, cardiovascular disease).
- Geographic Location: Must be residing in Jordan for the duration of the study and able to attend all scheduled assessment sessions at the specified study centers (University of Jordan).
- Informed Consent: Must provide voluntary written informed consent to participate in the study.
Who cannot join
- Pre-existing Conditions: Diagnosis of any chronic diseases, including cardiovascular disease, hypertension, diabetes mellitus, kidney disease, or any diagnosed neurological or immune system disorders.
- Medication Use: Currently using any prescription medications that could influence lipid metabolism, inflammatory status, or exercise performance (e.g., corticosteroids, statins, certain anti-inflammatory drugs).
- Supplement Use: Current or recent use (within the last 3 months) of any nutritional supplements Luteolin containing supplements. Failure to agree to restrict consumption of Luteolin-rich foods throughout the 12-week intervention period.
- Study Commitment: Inability or unwillingness to comply with the study protocol, including the 12-week daily capsule intake and attendance at all assessment visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Role of Luteolin Supplementation in Cellular Metabolism of Myocytes and Fat Cells by Regulating the Gene Expression of MEF2 and SREBP-1 Proteins, and Examining Its Effects on Physical Performance and Body Composition in Jordanian Athletes.
A clinical trial is to determine whether Luteolin supplementation can enhance cellular metabolism and improve physical performance in apparently healthy Jordanian male athletes aged 18-35 with continuous training experience.
The main questions it aims to answer are:
Read more
- Does 12 weeks of Luteolin supplementation increase the gene expression of MEF2 (a factor promoting muscle development and endurance)?
- Does 12 weeks of Luteolin supplementation decrease the gene expression of SREBP-1 (a factor regulating fat storage)?
- Does Luteolin supplementation lead to improvements in key performance metrics, such as maximal oxygen consumption VO2 max) and anaerobic power?
- Does Luteolin supplementation positively impact body composition, specifically by reducing fat mass and increasing lean muscle mass? Researchers will compare the group receiving the active Luteolin supplement (100 mg daily) to a placebo group receiving a microcrystalline cellulose supplement (a neutral substance) to determine whether the active supplement has the desired effects on metabolism, performance, and body composition.
Participants will:
- Take one capsule (either Luteolin or placebo) daily for 12 weeks.
- Continue their usual diet and exercise regimen but restrict intake of high-Luteolin foods during the study period.
- Provide a blood sample for gene expression analysis before and after the 12-week intervention.
- Undergo performance assessments, VO2 max and Wingate test, and body composition analysis (BIA) before and after the 12-week intervention.
Read the detailed description
This study is designed to evaluate Luteolin's potential to optimize metabolic health and physical performance in athletes by modulating specific transcription factors.
- Rationale: Effective management of lipid metabolism and enhanced muscle function are critical for athletic performance. Luteolin has shown in recent studies the potential to modulate gene expression, specifically activating MEF2 and downregulating SREBP-1.
- MEF2 Focus: Activation of MEF2 is linked to enhanced oxidative capacity, promotion of mitochondrial biogenesis, and improved muscle endurance, which are highly beneficial for athletes. Luteolin is thought to enhance MEF2 activity by promoting histone deacetylation.
- SREBP-1 Focus: SREBP-1 controls the expression of genes responsible for the synthesis of fatty acids and triglycerides. Downregulation of SREBP-1 is desirable for athletes to prevent excessive lipid accumulation and support better metabolic health and performance. Luteolin can inhibit the maturation of SREBP-1, reducing its activity and the expression of lipogenic genes.
- Design: A multi-center, double-blinded, placebo-controlled clinical trial will be conducted, requiring a total sample size of 50 male athletes. Outcome assessments include Real-Time PCR on blood samples for gene expression , Wingate and Vmax tests for performance , and Bioelectrical Impedance Analysis (BIA) for body composition.
- Conditions
- Healthy Athletes
- Being tested
- luteolin, Placebo
- Keywords
- luteolin, athlete, MEF-2, SREBP-1, anaerobic performance, body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
luteolinDietary supplement
100 mg Luteolin (Active Ingredient), taken orally once daily for 12 weeks.
PlaceboOther
Microcrystalline cellulose (Placebo), taken orally once daily for 12 weeks. The capsule is matched in size, color, and taste to the active Luteolin supplement.
| Study group | Role | What they receive |
|---|---|---|
| Luteolin Supplement | Experimental | Participants in this arm receive a daily 100 mg capsule of Luteolin for 12 continuous weeks. This arm aims to evaluate the effect of the active substance on MEF2 and SREBP-1gene expression, physical performance, and body composition. Receives: Dietary Supplement: luteolin |
| Placebo Control | Placebo comparator | Participants in this arm receive an identical-looking capsule containing only microcrystalline cellulose (a neutral substance) daily for 12 continuous weeks. This serves as the control against which the Luteolin group's outcomes will be compared. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SREBP-1 Gene Expression
Gene expression of SREBP-1 (Sterol Regulatory Element-Binding Protein 1) measured using Real-Time Polymerase Chain Reaction (RT-PCR) on collected salivary samples. The outcome is the fold change in expression from baseline to Week 12.
Measured: Baseline (Week 0) and End of Intervention (Week 12)
Change in MEF2 Gene Expression
Gene expression of MEF2 (Myocyte Enhancer Factor 2) measured using Real-Time Polymerase Chain Reaction (RT-PCR) on collected blood samples. The outcome is the fold change in expression from baseline to Week 12.
Measured: Baseline (Week 0) and End of Intervention (Week 12)
Secondary outcomes (3)
Change in Maximal Oxygen Consumption (Vo2 max)
VO2 max will be assessed via an incremental exercise test (e.g., Bruce protocol or similar) to measure cardiorespiratory fitness.
Measured: Baseline (Week 0) and End of Intervention (Week 12)
Change in Anaerobic Power (Wingate Test)
Peak and average anaerobic power will be determined using the standard 30-second Wingate Anaerobic Power Test.
Measured: Baseline (Week 0) and End of Intervention (Week 12)
Change in Body Composition (Fat Mass and Lean Mass)
Percentage of body fat and total lean muscle mass will be assessed using Bioelectrical Impedance Analysis (BIA).
Measured: Baseline (Week 0) and End of Intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Nov 2025
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AthletesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeel Ali Ghazzawi, University of Jordan
- Investigators
- Hadeel A Ghazzawi, professor, Principal investigator, The University of Jordan School of Agriculture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280520
- Sponsor's protocol ID
- 346 / 2025
- Other IDs
- 2025-148/2024
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of Luteolin Supplementation in Cellular Metabolism of Myocytes and Fat Cells by Regulating the Gene Expression of MEF2 and SREBP-1 Proteins, and Examining Its Effects on Physical Performance and Body Composition in Jordanian Athletes.
- ClinicalTrials.gov ID
- NCT07280520
- Acronym / sponsor ID
- 346 / 2025
- Conditions
- Healthy Athletes
- Keywords
- luteolin, athlete, MEF-2, SREBP-1, anaerobic performance, body composition
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 12 Dec 2025 (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.
A clinical trial is to determine whether Luteolin supplementation can enhance cellular metabolism and improve physical performance in apparently healthy Jordanian male athletes aged 18-35 with continuous training experience.
The main questions it aims to answer are:
- Does 12 weeks of Luteolin supplementation increase the gene expression of MEF2 (a factor promoting muscle development and endurance)?
- Does 12 weeks of Luteolin supplementation decrease the gene expression of SREBP-1 (a factor regulating fat storage)?
- Does Luteolin supplementation lead to improvements in key performance metrics, such as maximal oxygen consumption VO2 max) and anaerobic power?
- Does Luteolin supplementation positively impact body composition, specifically by reducing fat mass and increasing lean muscle mass? Researchers will compare the group receiving the active Luteolin supplement (100 mg daily) to a placebo group receiving a microcrystalline cellulose supplement (a neutral substance) to determine whether the active supplement has the desired effects on metabolism, performance, and body composition.
Participants will:
- Take one capsule (either Luteolin or placebo) daily for 12 weeks.
- Continue their usual diet and exercise regimen but restrict intake of high-Luteolin foods during the study period.
- Provide a blood sample for gene expression analysis before and after the 12-week intervention.
- Undergo performance assessments, VO2 max and Wingate test, and body composition analysis (BIA) before and after the 12-week intervention.
Detailed description
This study is designed to evaluate Luteolin's potential to optimize metabolic health and physical performance in athletes by modulating specific transcription factors.
- Rationale: Effective management of lipid metabolism and enhanced muscle function are critical for athletic performance. Luteolin has shown in recent studies the potential to modulate gene expression, specifically activating MEF2 and downregulating SREBP-1.
- MEF2 Focus: Activation of MEF2 is linked to enhanced oxidative capacity, promotion of mitochondrial biogenesis, and improved muscle endurance, which are highly beneficial for athletes. Luteolin is thought to enhance MEF2 activity by promoting histone deacetylation.
- SREBP-1 Focus: SREBP-1 controls the expression of genes responsible for the synthesis of fatty acids and triglycerides. Downregulation of SREBP-1 is desirable for athletes to prevent excessive lipid accumulation and support better metabolic health and performance. Luteolin can inhibit the maturation of SREBP-1, reducing its activity and the expression of lipogenic genes.
- Design: A multi-center, double-blinded, placebo-controlled clinical trial will be conducted, requiring a total sample size of 50 male athletes. Outcome assessments include Real-Time PCR on blood samples for gene expression , Wingate and Vmax tests for performance , and Bioelectrical Impedance Analysis (BIA) for body composition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Luteolin Supplement | Experimental | Dietary Supplement: luteolinParticipants in this arm receive a daily 100 mg capsule of Luteolin for 12 continuous weeks. This arm aims to evaluate the effect of the active substance on MEF2 and SREBP-1gene expression, physical performance, and body composition. |
| Placebo Control | Placebo comparator | Other: PlaceboParticipants in this arm receive an identical-looking capsule containing only microcrystalline cellulose (a neutral substance) daily for 12 continuous weeks. This serves as the control against which the Luteolin group's outcomes will be compared. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gender and Age: Male volunteers aged 18 to 35 years old.
- Athletic Status: Currently training male athletes with continuous sports training experience in any field (e.g., endurance, team sports, strength training).
- Health Status: Apparently healthy, with no known chronic diseases or metabolic disorders that could interfere with lipid or muscle metabolism (e.g., diabetes, liver disease, kidney disease, cardiovascular disease).
- Geographic Location: Must be residing in Jordan for the duration of the study and able to attend all scheduled assessment sessions at the specified study centers (University of Jordan).
- Informed Consent: Must provide voluntary written informed consent to participate in the study.
Key exclusion criteria (4 listed)
- Pre-existing Conditions: Diagnosis of any chronic diseases, including cardiovascular disease, hypertension, diabetes mellitus, kidney disease, or any diagnosed neurological or immune system disorders.
- Medication Use: Currently using any prescription medications that could influence lipid metabolism, inflammatory status, or exercise performance (e.g., corticosteroids, statins, certain anti-inflammatory drugs).
- Supplement Use: Current or recent use (within the last 3 months) of any nutritional supplements Luteolin containing supplements. Failure to agree to restrict consumption of Luteolin-rich foods throughout the 12-week intervention period.
- Study Commitment: Inability or unwillingness to comply with the study protocol, including the 12-week daily capsule intake and attendance at all assessment visits.
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 |
|---|---|---|
| luteolin100 mg Luteolin (Active Ingredient), taken orally once daily for 12 weeks. | Dietary supplement | Luteolin Supplement |
| PlaceboMicrocrystalline cellulose (Placebo), taken orally once daily for 12 weeks. The capsule is matched in size, color, and taste to the active Luteolin supplement. | Other | Placebo Control |
Primary outcome
Change in SREBP-1 Gene Expression
Time frame: Baseline (Week 0) and End of Intervention (Week 12)
Gene expression of SREBP-1 (Sterol Regulatory Element-Binding Protein 1) measured using Real-Time Polymerase Chain Reaction (RT-PCR) on collected salivary samples. The outcome is the fold change in expression from baseline to Week 12.
Change in MEF2 Gene Expression
Time frame: Baseline (Week 0) and End of Intervention (Week 12)
Gene expression of MEF2 (Myocyte Enhancer Factor 2) measured using Real-Time Polymerase Chain Reaction (RT-PCR) on collected blood samples. The outcome is the fold change in expression from baseline to Week 12.
3 secondary outcomes
Change in Maximal Oxygen Consumption (Vo2 max)
Time frame: Baseline (Week 0) and End of Intervention (Week 12)
Change in Anaerobic Power (Wingate Test)
Time frame: Baseline (Week 0) and End of Intervention (Week 12)
Change in Body Composition (Fat Mass and Lean Mass)
Time frame: Baseline (Week 0) and End of Intervention (Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
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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.
Hadeel A Ghazzawi, professor principal investigator
The University of Jordan School of Agriculture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing luteolin in people with Healthy Athletes, run by University of Jordan at 1 site in Jordan.
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 5 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: enrolling by invitation, as of the sponsor's last update on 12 Dec 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 Jordan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in SREBP-1 Gene Expression (time frame: Baseline (Week 0) and End of Intervention (Week 12)). 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 12 Dec 2025.