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.
Postmenopausal women aged 40-75 years.
Free from chronic diseases and not taking regular medications.
Individuals with chronic diseases.
Individuals with known allergies to the study materials.
Individuals currently taking nutritional supplements that may interfere with the study outcomes.
Crossover
French maritime pine bark extract
Dietary supplementparticipants 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
Other interventionparticipants 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.
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.
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.
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.
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.
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.
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.
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.
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.
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Taipei Medical University
Lead sponsor
QWB
Collaborator
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