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

NCT07280520 | Enrolling By Invitation

• 2 other identifiers: 346 / 20252025-148/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Athletes

Keywords

luteolin; athlete; MEF-2; SREBP-1; anaerobic performance; body composition

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline (Week 0) and End of Intervention (Week 12)

Secondary Outcomes (3)

• Change in Maximal Oxygen Consumption (Vo2 max)

  Baseline (Week 0) and End of Intervention (Week 12)

• Change in Anaerobic Power (Wingate Test)

  Baseline (Week 0) and End of Intervention (Week 12)

• Change in Body Composition (Fat Mass and Lean Mass)

  Baseline (Week 0) and End of Intervention (Week 12)

Study Arms (2)

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.

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.

Other: Placebo

Interventions

luteolin DIETARY_SUPPLEMENT

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

Luteolin Supplement

Placebo 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.

Placebo Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Male volunteers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

University of Jordan (UJ)

Amman, Amman Governorate, 11942, Jordan

Location

MeSH Terms

Interventions

Luteolin

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hadeel A Ghazzawi, professor

  The University of Jordan School of Agriculture

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Model Description

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: November 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediately following publication
• Access Criteria: Data will be available upon request to researchers who provide a methodologically sound proposal and who have obtained ethical approval from a relevant Institutional Review Board (IRB) or Ethics Committee.

Locations

JO (1)