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

NCT07855198 | Not Yet Recruiting

• 1 other identifier: N202605084
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gene Expression; Nutrigenomics

Keywords

pine bark extract; Postmenopausal women; antioxidant; Anti-inflammatory; Quality of life

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (21)

• Antioxidative enzyme activities

  At the start of the experiment and at the Day 30

• Antioxidant-related gene expression

  At the start of the experiment and at the Day 30

• Inflammation-related gene expression

  At the start of the experiment and at the Day 30

• Lipid profile

  At the start of the experiment and at the Day 30

• Anthropometric measurements

  At the start of the experiment and at the Day 30

Study Arms (2)

French maritime pine bark extract

EXPERIMENTAL

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

Placebo Comparator: placebo

PLACEBO COMPARATOR

Placebo treatment ( identical capsules containing maltodextrin and magnesium stearate)

Other: Placebo

Interventions

French maritime pine bark extract DIETARY_SUPPLEMENT

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.

French maritime pine bark extract

Placebo OTHER

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

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• QWB: collaborator
• Taipei Medical University: lead

MeSH Terms

Interventions

pycnogenols

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: October 2, 2026
• Study Start: September 7, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-08