Resveratrol Effects on Inflammatory Biomarkers and Cardiometabolic Parameters.

Официальное название

Effects of Resveratrol Supplementation on Inflammatory Biomarkers and Cardiometabolic Parameters in Community-dwelling Adults. (RESINCA-trial)

Обзор

This study aims to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers and cardiometabolic parameters in community-dwelling adults

Подробное описание

Three groups will be studied: control group (RES 120), experimental group 1 (RES 250) and experimental group 2 (RES 500).

During 8 weeks the RES 120 group will received daily one grape pomace bars with 120 mg of total polyphenols contents (TPC), the RES 250 group will received daily one grape pomace bars enriched with resveratrol until reach 250 mg of TPC and the RES 500 group will received daily one grape pomace bars enriched with resveratrol until reach 500 mg of TPC.

Outcomes will be assessed at baseline and after 8 weeks.

At the end of the study, the groups that shows less o no effects will be invited to enjoy the bar showing to be more effective.

Primary outcomes are: Total plasma antioxidant capacity (TAC), ultra-sensitivity CRP, IL-6, TNF-alfa, plasma malondialdehyde and AGEs.

Secondary outcomes are: body weight, Body Mass Index (BMI), basal metabolic rate, fat mass, skeletal muscle mass, and waist-to-hip ratio. Handgrip strength, 30-second sit-to-stand test, and heart rate variability. Fasting insulin, fasting glucose, HOMA-IR. Lipid profile, liver profile, blood pressure.

All procedures will be performed at the clinical simulation center of the Faculty of Medicine of the Catholic University of Maule.

The sample size was estimated under the following criteria, using G\*Power software (version 3.1):

Primary outcome: Total Plasma Antioxidant Capacity (TAC). Type of comparison: differences between parallel groups. Level of significance (α): 0.05 (bilateral). Stat (1 - β): 80%. Minimum expected difference (Δ): 0.25 TAC units. Standard deviation (σ): 0.30 TAC units. Balanced allocation between groups (1:1:1). The minimum sample size required is 23 participants per group, considering an estimated loss or dropout rate of 15-20%, the sample size was increased to 27- 30 participants per group.

Вмешательства

• Пищевая добавка RES 120
  This grape pomace bar have 120 mg of total polyphenols contents
• Пищевая добавка RES 250
  This grape pomace bar is enriched with resveratrol until reach 250 mg of total polyphenols contents
• Пищевая добавка RES 500
  This grape pomace bar is enriched with resveratrol until reach 500 mg of total polyphenols contents

Первичные конечные точки

• Inflammatory biomarkers: Total plasma antioxidant capacity (µmol/L). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Inflammatory Biomarkers: Ultra-sensitivity CRP (mg/L). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Inflammatory Biomarkers: IL-6 (pg/mL). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Inflammatory Biomarkers: Plasma malondialdehyde (µmol/L). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Inflammatory Biomarkers: TNF-alfa (pg/mL). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Inflammatory Biomarkers: Advanced glycation end-products (AGEs) in 1 to 5 units. [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (12)

• Cardiometabolic Parameters: Body weight (kg). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cardiometabolic Parameters: Body mass index-BMI (kg/m2). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cardiometabolic Parameters: Basal metabolic rate (kcal). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cardiometabolic Parameters: Fat mass (kg, %). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cardiometabolic Parameters: Skeletal muscle mass (kg). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cardiometabolic Parameters: Waist-to-hip ratio. [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cardiometabolic Parameters: Handgrip strength (kg). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cardiometabolic Parameters: 30-second sit-to-stand test (n° of repetitions achieved). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cardiometabolic parameters: HRV, RMSSD and SDNN in (ms). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cardiometabolic parameters: PNN50 (%). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cardiometabolic parameters: Insuline (µIU/mL). [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cardiometabolic parameters: Glucose (mg/dL). [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• Comunnity-dwelling persons.
• Any ethnicity.
• With willingness to consume the bar daily during the intervention period.

Критерии исключения

• Allergy/intolerance to ingredients in the bar.
• Pregnancy or breastfeeding.
• Use of antioxidant/polymeroid supplements in the last 4 weeks.
• Unstable chronic diseases (e.g., severe liver failure, advanced kidney failure, active cancer).
• Persons in treatments that strongly interfere with polyphenol metabolism (e.g., antibiotics, anti-inflammatories, corticosteroids, anti-allergy medication).
• Persons with metal prosthesis.
• Persons undergoing or waiting for metabolic bariatric surgery.
• Persons with scheduled digestive surgery within the next 8 weeks
• Persons in recent treatments for hypertension (less than 3 month).
• Participation in another clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Чили · 1 центр

• Universidad Católica del Maule — Talca

Публикации

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• Breuss JM, Atanasov AG, Uhrin P. Resveratrol and Its Effects on the Vascular System. Int J Mol Sci. 2019 Mar 27;20(7):1523. doi: 10.3390/ijms20071523. PMID 30934670
• Huang H, Chen G, Liao D, Zhu Y, Pu R, Xue X. The effects of resveratrol intervention on risk markers of cardiovascular health in overweight and obese subjects: a pooled analysis of randomized controlled trials. Obes Rev. 2016 Dec;17(12):1329-1340. doi: 10.1111/obr.12458. Epub 2016 Jul 26. PMID 27456934
• Springer M, Moco S. Resveratrol and Its Human Metabolites-Effects on Metabolic Health and Obesity. Nutrients. 2019 Jan 11;11(1):143. doi: 10.3390/nu11010143. PMID 30641865
• Pastor RF, Restani P, Di Lorenzo C, Orgiu F, Teissedre PL, Stockley C, Ruf JC, Quini CI, Garcia Tejedor N, Gargantini R, Aruani C, Prieto S, Murgo M, Videla R, Penissi A, Iermoli RH. Resveratrol, human health and winemaking perspectives. Crit Rev Food Sci Nutr. 2019;59(8):1237-1255. doi: 10.1080/10408398.2017.1400517. Epub 2017 Dec 5. PMID 29206058
• Chudzinska M, Rogowicz D, Wolowiec L, Banach J, Sielski S, Bujak R, Sinkiewicz A, Grzesk G. Resveratrol and cardiovascular system-the unfulfilled hopes. Ir J Med Sci. 2021 Aug;190(3):981-986. doi: 10.1007/s11845-020-02441-x. Epub 2020 Nov 21. PMID 33219913
• Hou CY, Tain YL, Yu HR, Huang LT. The Effects of Resveratrol in the Treatment of Metabolic Syndrome. Int J Mol Sci. 2019 Jan 28;20(3):535. doi: 10.3390/ijms20030535. PMID 30695995
• Mousavi SM, Milajerdi A, Sheikhi A, Kord-Varkaneh H, Feinle-Bisset C, Larijani B, Esmaillzadeh A. Resveratrol supplementation significantly influences obesity measures: a systematic review and dose-response meta-analysis of randomized controlled trials. Obes Rev. 2019 Mar;20(3):487-498. doi: 10.1111/obr.12775. Epub 2018 Dec 5. PMID 30515938

Идентификаторы

NCT: NCT07395921 · ECA Resveratrol - FIC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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