The Role of Luteolin Supplementation in Cellular Metabolism of Myocytes and Fat Cells, Physical Performance, and Body Composition in Athletes.

NCT ID: NCT07280520

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Luteolin Supplement

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.

Group Type: EXPERIMENTAL

luteolin

Intervention Type: DIETARY_SUPPLEMENT

100 mg Luteolin (Active Ingredient), taken orally once daily for 12 weeks.

Placebo Control

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Microcrystalline cellulose (Placebo), taken orally once daily for 12 weeks. The capsule is matched in size, color, and taste to the active Luteolin supplement.

Interventions

Placebo

Microcrystalline cellulose (Placebo), taken orally once daily for 12 weeks. The capsule is matched in size, color, and taste to the active Luteolin supplement.

Intervention Type: OTHER

luteolin

100 mg Luteolin (Active Ingredient), taken orally once daily for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Hadeel Ali Ghazzawi

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hadeel A Ghazzawi, professor

Role: PRINCIPAL_INVESTIGATOR

The University of Jordan School of Agriculture

Locations

University of Jordan (UJ)

Amman, Amman Governorate, Jordan

Countries

Jordan

Other Identifiers

2025-148/2024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

346 / 2025

Identifier Type: -

Identifier Source: org_study_id