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.
Studie Overzicht
Toestand
Toestand
Conditie
Conditie
Interventie / Behandeling
Interventie / Behandeling
Studietype
Studietype
Inschrijving (Geschat)
Inschrijving
Fase
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Aantal wapens
Wapens en interventies
Deelnemersgroep / ArmDeelnemersgroep / Arm |
Interventie / BehandelingInterventie / Behandeling |
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Experimenteel: 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. |
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. |
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Placebo-vergelijker: Placebo Comparator: placebo
Placebo treatment ( identical capsules containing maltodextrin and magnesium stearate) |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from Baseline quality-of-life (QoL) in 30 days
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
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Antioxidative status
Tijdsspanne: At baseline and Day 30
|
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
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Antioxidative status
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
|
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Antioxidative status
Tijdsspanne: At baseline and Day 30
|
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
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Antioxidative status
Tijdsspanne: At baseline and Day 30
|
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
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Inflammatory status
Tijdsspanne: At the start of the experiment and at the Day 30
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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
|
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Inflammatory status
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
|
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Inflammatory status
Tijdsspanne: At the start of the experiment and at the Day 30
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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
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Inflammatory status
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
|
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Anti-inflammatory status
Tijdsspanne: At the start of the experiment and at the Day 30
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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
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Anti-inflammatory status
Tijdsspanne: At the start of the experiment and at the Day 30
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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
|
Secundaire uitkomstmaten
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Antioxidative enzyme activities
Tijdsspanne: At the start of the experiment and at the Day 30
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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
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Antioxidant-related gene expression
Tijdsspanne: At the start of the experiment and at the Day 30
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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
|
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Inflammation-related gene expression
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
|
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Lipid profile
Tijdsspanne: At the start of the experiment and at the Day 30
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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
|
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Anthropometric measurements
Tijdsspanne: At the start of the experiment and at the Day 30
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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
|
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Antioxidative enzyme activities
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
|
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Antioxidative enzyme activities
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
|
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Antioxidative enzyme activities
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
|
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Liver function
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
|
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Kidney function
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
|
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Hematology
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
|
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Anthropometric measurements
Tijdsspanne: At the start of the experiment and at the Day 30
|
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
|
Medewerkers en onderzoekers
Sponsor
Sponsor
Medewerkers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Studie start
Primaire voltooiing (Geschat)
Primaire voltooiing
Studie voltooiing (Geschat)
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
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Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update geplaatst
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
Andere studie-ID-nummers
- N202605084
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