BERBERINE SUPPLEMENTATIONS (Berberine)
EFFECTS OF BARBERRY (BERBERIS VULGARIS) SUPPLEMENTATIONS ON ANTIOXIDANT AND OKSIDANT CAPASITY IN HEALTHY ADULTS
This randomized, placebo-controlled interventional study aims to evaluate the effects of 60 days of supplementation with a liposomal Berberis vulgaris-based product on antioxidant status, selected biochemical parameters, body weight, body mass index (BMI), and body composition in healthy adult volunteers. The planned total enrollment is 40 participants. The intervention group will receive one 200 mg capsule daily for 60 days, subject to confirmation of the product's composition and labeling. The comparator group will receive a placebo according to the approved study protocol. Total antioxidant capacity (TAC), total oxidant status (TOS), and other prespecified outcomes will be assessed using the methods and time points defined in the protocol.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
At baseline, participants who meet the inclusion and exclusion criteria and provide written informed consent will undergo anthropometric measurements, including body weight, height, and body composition, at the Healthy Nutrition Counseling Unit of the Faculty of Health Sciences, Sivas Cumhuriyet University. Medical history and demographic information will also be collected using a personal information form. Blood samples will be collected at the Biochemistry Laboratory of Sivas Cumhuriyet University Hospital to assess routine biochemical parameters, including glucose, insulin, renal and liver function markers, lipid profile, electrolytes, and uric acid. Blood results will be evaluated by a study physician. During the 60-day supplementation period, participants will be contacted by telephone every 15 days. Dietary intake will be assessed using 24-hour dietary recalls, and appetite status will be evaluated using the Simplified Nutrition and Appetite Questionnaire. Adherence to the intervention will be monitored through these calls and verified at the end of the study by checking the returned supplement packages and unused capsules. At baseline and at the end of the study, blood samples will also be analyzed for total antioxidant capacity (TAC), total oxidant status (TOS), paraoxonase-1 (PON1), and arylesterase (ARE) activities. Serum samples will be separated by centrifugation and stored at -80°C until analysis. TAC and TOS will be assessed as the primary outcome measures, while PON1 and ARE activities will provide additional information on enzymatic antioxidant defense. These measurements will enable a comprehensive evaluation of the effects of Berberis vulgaris supplementation on oxidative balance and antioxidant defense.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: EMİNE DİNÇER, Doç.Dr.
- Numéro de téléphone: 90+5529446064
- E-mail: edincer@cumhuriyet.edu.tr
Sauvegarde des contacts de l'étude
- Nom: ÖZGE AKTAŞ, Dyt
- Numéro de téléphone: 90+5523405058
- E-mail: aktsozge58@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adults aged 18-65 years.
- Individuals with a body mass index (BMI) between 18,5 and 29,99 kg/m².
- Individuals who voluntarily agree to participate in the study.
- Individuals with no known medication sensitivities.
- Individuals with no known food allergies.
- Individuals who do not use medications that may affect appetite, body weight, or related parameters.
- Individuals who do not use any dietary supplements.
Exclusion Criteria:
- Pregnant or breastfeeding women.
- Individuals who smoke.
- Individuals with any medical condition that may affect the study outcomes, including diabetes mellitus, chronic obstructive pulmonary disease (COPD), and cardiovascular diseases.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Experimental
Lipozomal Berberis Vulgaris Supplementation. Participants will receive one capsule daily for 60 days. The stated capsule strength is 200 mg. The amount of Berberis vulgaris extract and/or berberine per capsule, product composition, and route of administration must be confirmed from the product documentation. |
Participants will receive one capsule daily for 60 days. The stated capsule strength is 200 mg. The amount of Berberis vulgaris extract and/or berberine per capsule, product composition, and route of administration must be confirmed from the product documentation. |
|
Comparateur placebo: Placebo
Placebo Supplementation. Participants will receive a placebo according to the approved study protocol for 60 days. The dosage form, administration schedule, and matching characteristics will be specified based on the protocol. |
Participants will receive a placebo according to the approved study protocol for 60 days. The dosage form, administration schedule, and matching characteristics will be specified based on the protocol. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Total Antioxidant Capacity (TAC)
Délai: Baseline and Day 61
|
Change in total antioxidant capacity from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits. |
Baseline and Day 61
|
|
Change in Total Oxidant Status (TOS)
Délai: Baseline and Day 61
|
Change in total oxidant status from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits. |
Baseline and Day 61
|
|
Change in Body Weight
Délai: Baseline and Day 61
|
Change in body weight from baseline to the end of the intervention, measured in kilograms. |
Baseline and Day 61
|
|
Change in Body Mass Index (BMI)
Délai: Baseline and Day 61
|
Change in body mass index from baseline to the end of the intervention, weight and height will be combined to report BMI in kg/m^2). |
Baseline and Day 61
|
|
Change in Body Composition
Délai: Baseline and Day 61
|
Change from baseline in the prespecified body composition parameters assessed using TANITA MC 780MA. |
Baseline and Day 61
|
|
Change in Biochemical Parameters
Délai: Baseline and Day 61
|
Change from baseline to the end of the intervention in each prespecified biochemical parameter. |
Baseline and Day 61
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in paraoksonaz-1 (PON1)
Délai: Baseline and Day 61.
|
Change in paraoksonaz-1 (PON1) from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits. |
Baseline and Day 61.
|
|
Change in arilesteraz (ARE)
Délai: Baseline and Day 61.
|
Change in arilesteraz (ARE) from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits. |
Baseline and Day 61.
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Publications générales
- Vahedi-Mazdabadi Y, Shahinfar H, Toushih M, Shidfar F. Effects of berberine and barberry on selected inflammatory biomarkers in adults: A systematic review and dose-response meta-analysis of randomized clinical trials. Phytother Res. 2023 Dec;37(12):5541-5557. doi: 10.1002/ptr.7998. Epub 2023 Sep 7.
- Shidfar F, Ebrahimi SS, Hosseini S, Heydari I, Shidfar S, Hajhassani G. The Effects of Berberis vulgaris Fruit Extract on Serum Lipoproteins, apoB, apoA-I, Homocysteine, Glycemic Control and Total Antioxidant Capacity in Type 2 Diabetic Patients. Iran J Pharm Res. 2012 Spring;11(2):643-52.
- Shakeri F, Kiani S, Rahimi G, Boskabady MH. Anti-inflammatory, antioxidant, and immunomodulatory effects of Berberis vulgaris and its constituent berberine, experimental and clinical, a review. Phytother Res. 2024 Apr;38(4):1882-1902. doi: 10.1002/ptr.8077. Epub 2024 Feb 15.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- SBF-2026-125
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
There is no plan to make individual participant data available due to institutional data privacy regulations and conditions of the informed consent form signed by the participants.
Informations sur les médicaments et les dispositifs, documents d'étude
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