Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-03-11 @ 11:44 PM
Study NCT ID:
NCT07280520
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-12
First Post:
2025-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Luteolin Supplementation in Cellular Metabolism of Myocytes and Fat Cells, Physical Performance, and Body Composition in Athletes.
Sponsor:
University of Jordan
Organization:
Study Overview
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.
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-148/2024 | OTHER_GRANT | University of Jordan | View |