The Improving Effects of French Maritime Pine Bark Extract on Antioxidation and Anti-inflammation a in Post-menopausal Women Based on Nutrigenomic Approach

The goal of this clinical trial is to investigate whether French maritime pine bark extract (FMPBE) supplementation can improve antioxidant capacity and reduce inflammation in postmenopausal women aged 40-75 years.

The main questions it aims to answer are:

Does FMPBE supplementation improve antioxidant status and reduce oxidative stress? Does FMPBE supplementation reduce inflammatory responses and affect related gene expression? Researchers will compare an FMPBE treatment group with a placebo group. Participants will take one capsule daily for 30 days and undergo blood collection on Day 0 and Day 30 for biochemical and gene expression analyses. Participants will also complete assessments of anthropometric measurements, blood pressure, dietary intake, and quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Gene Expression; Nutrigenomics
• Intervention / Treatment: Dietary supplement: French maritime pine bark extract; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Postmenopausal women aged 40-75 years.
• Free from chronic diseases and not taking regular medications.

Exclusion Criteria:

• Individuals with chronic diseases.
• Individuals with known allergies to the study materials.
• Individuals currently taking nutritional supplements that may interfere with the study outcomes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: French maritime pine bark extract; Dietary supplement: French maritime pine bark extract(contains sesamin 100 mg per capsule) This group will be given supplements for 30 days.	Dietary supplement: French maritime pine bark extract; participants who meet the inclusion criteria will be randomly divided into Placebo (P) and treatment (T) groups. Participants in the P group will be provided with one capsule of placebo without FMPBE whereas participants in the T group will be provided with one capsule of placebo with FMPBE (100mg) per day for 30 days. Blood samples will be collected on Day 0 and Day 30 for biochemical and genetic analyses, accompanied by the administration of a quality-of-life (QoL) questionnaire to assess participants' overall well-being. At the same time, they will accept the measurement of anthropometric measurements and blood pressure, also be interviewed with 24 hours dietary recall questionnaire.
Placebo Comparator: Placebo Comparator: placebo; Placebo treatment ( identical capsules containing maltodextrin and magnesium stearate)	Other: Placebo; participants who meet the inclusion criteria will be randomly divided into Placebo (P) and treatment (T) groups. Participants in the P group will be provided with one capsule of placebo without FMPBE whereas participants in the T group will be provided with one capsule of placebo with FMPBE (100mg) per day for 30 days. Blood samples will be collected on Day 0 and Day 30 for biochemical and genetic analyses, accompanied by the administration of a quality-of-life (QoL) questionnaire to assess participants' overall well-being. At the same time, they will accept the measurement of anthropometric measurements and blood pressure, also be interviewed with 24 hours dietary recall questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline quality-of-life (QoL) in 30 days	Quality of life will be assessed using the Menopause-specific Quality of Life (MENQOL) questionnaire, consisting of 53 items. Each item is scored on a 6-point scale from 1 to 6, with higher scores indicating better quality of life. The total score ranges from 53 to 318, with higher total scores indicating better quality of life. The questionnaire assesses menopause-related symptoms and disturbances experienced during the preceding 1-month period.	At the start of the experiment and at the Day 30
Antioxidative status	Change from baseline in plasma thiobarbituric acid-reactive substances (TBARS) concentration at Day 30.Plasma TBARS concentration will be measured as an indicator of lipid peroxidation and oxidative stress. The concentration will be reported in nmol/ml.	At baseline and Day 30
Antioxidative status	Change from baseline in erythrocytic reduced glutathione-to-oxidized glutathione ratio (GSH/GSSG ratio) at Day 30.The ratio of reduced glutathione (GSH) to oxidized glutathione (GSSG) in erythrocytes will be calculated as an indicator of cellular redox status. The ratio will be reported as a unitless value.	At the start of the experiment and at the Day 30
Antioxidative status	Change from baseline in erythrocytic reduced glutathione (GSH) concentration at Day 30.Erythrocytic reduced glutathione (GSH) concentration will be measured and reported in μmol/g Hb.	At baseline and Day 30
Antioxidative status	Change from baseline in plasma reduced glutathione (GSH) concentration at Day 30.Plasma reduced glutathione (GSH) concentration will be measured and reported in µmol/L.	At baseline and Day 30
Inflammatory status	Change from baseline in plasma tumor necrosis factor-alpha (TNF-α) concentration at Day 30.Plasma TNF-α concentration will be measured and reported in pg/mL.	At the start of the experiment and at the Day 30
Inflammatory status	Change from baseline in plasma interleukin-1 beta (IL-1β) concentration at Day 30.Plasma IL-1β concentration will be measured and reported in pg/mL.	At the start of the experiment and at the Day 30
Inflammatory status	Change from baseline in plasma interleukin-6 (IL-6) concentration at Day 30.Plasma IL-6 concentration will be measured and reported in pg/mL.	At the start of the experiment and at the Day 30
Inflammatory status	Change from baseline in plasma high-sensitivity C-reactive protein (hsCRP) concentration at Day 30.Plasma hsCRP concentration will be measured and reported in mg/dL.	At the start of the experiment and at the Day 30
Anti-inflammatory status	Change from baseline in plasma interleukin-10 (IL-10) concentration at Day 30.Plasma IL-10 concentration will be measured and reported in pg/mL.	At the start of the experiment and at the Day 30
Anti-inflammatory status	Change from baseline in plasma transforming growth factor-beta (TGF-β) concentration at Day 30.Plasma TGF-β concentration will be measured and reported in pg/mL.	At the start of the experiment and at the Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antioxidative enzyme activities	Change from baseline in erythrocytic superoxide dismutase (SOD) activity at Day 30.Erythrocytic SOD activity will be measured and reported in U/mg Hb.	At the start of the experiment and at the Day 30
Antioxidant-related gene expression	Relative gene expression levels of antioxidant-related genes, including SOD1, SOD2, SOD3, CAT, GPX1, GPX3, GR, and HMOX1, measured in whole blood by reverse transcription quantitative polymerase chain reaction (RT-qPCR). Gene expression levels will be expressed as relative expression values (fold change) using the prespecified reference gene and analysis method.	At the start of the experiment and at the Day 30
Inflammation-related gene expression	Relative gene expression levels of inflammation-related genes, including tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6), will be measured in whole blood using reverse transcription quantitative polymerase chain reaction (RT-qPCR). Gene expression levels will be expressed as relative expression values (fold change) using the prespecified reference gene and analysis method.	At the start of the experiment and at the Day 30
Lipid profile	Change from baseline in lipid profile at Day 30.Serum high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and total cholesterol (TC) will be assessed and reported in mg/dL.	At the start of the experiment and at the Day 30
Anthropometric measurements	Change from baseline in body weight at Day 30.Body weight will be measured in kilograms (kg).	At the start of the experiment and at the Day 30
Antioxidative enzyme activities	Change from baseline in plasma superoxide dismutase (SOD) activity at Day 30.Plasma SOD activity will be measured and reported in U/mL.	At the start of the experiment and at the Day 30
Antioxidative enzyme activities	Change from baseline in erythrocytic catalase (CAT) activity at Day 30.Erythrocytic CAT activity will be measured and reported in U/mg Hb.	At the start of the experiment and at the Day 30
Antioxidative enzyme activities	Change from baseline in plasma catalase (CAT) activity at Day 30.Plasma CAT activity will be measured and reported in U/mL.	At the start of the experiment and at the Day 30
Antioxidative enzyme activities	Change from baseline in erythrocytic glutathione reductase (GR) activity at Day 30.Erythrocytic GR activity will be measured and reported in U/g Hb.	At the start of the experiment and at the Day 30
Antioxidative enzyme activities	Change from baseline in plasma glutathione reductase (GR) activity at Day 30.Plasma GR activity will be measured and reported in U/L.	At the start of the experiment and at the Day 30
Antioxidative enzyme activities	Change from baseline in erythrocytic glutathione peroxidase (GPX) activity at Day 30.Erythrocytic GPX activity will be measured and reported in U/g Hb.	At the start of the experiment and at the Day 30
Antioxidative enzyme activities	Change from baseline in plasma glutathione peroxidase (GPX) activity at Day 30.Plasma GPX activity will be measured and reported in U/L.	At the start of the experiment and at the Day 30
anti-inflammation-related gene expression	Relative gene expression levels of anti-inflammatory-related genes, including interleukin-10 (IL-10) and transforming growth factor-beta (TGF-β), will be measured in whole blood using reverse transcription quantitative polymerase chain reaction (RT-qPCR). Gene expression levels will be expressed as relative expression values (fold change) using the prespecified reference gene and analysis method.	At the start of the experiment and at the Day 30
Regulatory and Redox-related Gene Expression	Relative gene expression levels of interferon regulatory factor 2 (IRF2), nuclear factor kappa B (NF-κB), nuclear factor erythroid 2-related factor 2 (NRF2), and Kelch-like ECH-associated protein 1 (KEAP1) will be measured in whole blood using reverse transcription quantitative polymerase chain reaction (RT-qPCR). Gene expression levels will be expressed as relative expression values (fold change) using the prespecified reference gene and analysis method.	At the start of the experiment and at the Day 30
Liver function	Change from baseline in liver function parameters at Day 30. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels will be assessed and reported in U/L.	At the start of the experiment and at the Day 30
Kidney function	Change from baseline in kidney function parameters at Day 30.Serum blood urea nitrogen (BUN), creatinine, and uric acid levels, as well as estimated glomerular filtration rate (eGFR), will be assessed. BUN, creatinine, and uric acid will be reported in mg/dL, and eGFR will be reported in mL/min.	At the start of the experiment and at the Day 30
Hematology	WBC (10^3/uL), RBC (10^6/uL), hemoglobin (g/dL), hematocrit (%), MCV(fL), MCH (pg), MCHC (g/dL), platelet (10^3/uL), neutrophils (%), lymphocytes (%), monocytes (%), eosinophils (%) and basophils(%)	At the start of the experiment and at the Day 30
Anthropometric measurements	Change from baseline in height and waist circumference at Day 30.Height and waist circumference will be measured and reported in centimeters (cm)	At the start of the experiment and at the Day 30
Anthropometric measurements	Change from baseline in body composition at Day 30.Body composition will be assessed by body fat percentage and skeletal muscle percentage, both reported as percentages (%).	At the start of the experiment and at the Day 30
Anthropometric measurements	Change from baseline in body mass index (BMI) at Day 30 Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared and reported in kg/m².	At the start of the experiment and at the Day 30
Anthropometric measurements	Change from baseline in blood pressure at Day 30 Blood pressure will be assessed by measuring systolic blood pressure and diastolic blood pressure, both reported in millimeters of mercury (mmHg).	At the start of the experiment and at the Day 30

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: QWB

Study record dates

Study Major Dates

• Study Start (Estimated): September 7, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: September 7, 2026
• First Submitted That Met QC Criteria: September 29, 2026
• First Posted (Actual): October 2, 2026

Study Record Updates

• Last Update Posted (Actual): October 2, 2026
• Last Update Submitted That Met QC Criteria: September 29, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Anti-inflammatory; antioxidant; Postmenopausal women; pine bark extract
• Additional Relevant MeSH Terms: pycnogenols
• Other Study ID Numbers: N202605084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No