Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universidad Católica del Maule | OTHER |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RES 120 | Sham Comparator | This is the control group |
|
| RES 250 | Experimental | This is the experimental group 1 |
|
| RES 500 | Experimental | This is the experimental group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RES 120 | Dietary Supplement | This grape pomace bar have 120 mg of total polyphenols contents |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory biomarkers: Total plasma antioxidant capacity (µmol/L). | The total plasma antioxidant capacity by Ferric Reducing Antioxidant Power will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Inflammatory Biomarkers: Ultra-sensitivity CRP (mg/L). | The ultra-sensitivity CRP by Elisa test will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Inflammatory Biomarkers: IL-6 (pg/mL). | The IL-6 by Elisa test will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Inflammatory Biomarkers: Plasma malondialdehyde (µmol/L). | The plasma malondialdehyde by TBARS/HPLC method will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Inflammatory Biomarkers: TNF-alfa (pg/mL). | The TNF-alfa by Elisa test will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiometabolic Parameters: Body weight (kg). | Body weight will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ileana González Bonet, Dr | Contact | +56 71 2986000 | ileanag@ucm.cl | |
| Andrea Herrera Santelices, Dr | Contact | +56 71 2986000 | aherreras@ucm.cl |
| Name | Affiliation | Role |
|---|---|---|
| Gerard Casaubon Cruzat | Center for Research and Innovation Viña Concha y Toro | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Católica del Maule | Talca | Maule Region | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28894509 | Background | Chiva-Blanch G, Badimon L. Effects of Polyphenol Intake on Metabolic Syndrome: Current Evidences from Human Trials. Oxid Med Cell Longev. 2017;2017:5812401. doi: 10.1155/2017/5812401. Epub 2017 Aug 15. | |
| 30934670 | Background | 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. |
Not provided
Not provided
In order to protect the privacy, data will be stored and coded. At the end of the study, data may be available upon a reasonable request and ensuring the participants' data confidentiality will be preserved.
Not provided
Not provided
Not provided
Not provided
Not provided
This Clinical Trial will be carried out with 3 parallel arms.
Not provided
Not provided
Not provided
| RES 250 | Dietary Supplement | This grape pomace bar is enriched with resveratrol until reach 250 mg of total polyphenols contents |
|
|
| RES 500 | Dietary Supplement | This grape pomace bar is enriched with resveratrol until reach 500 mg of total polyphenols contents |
|
|
| From enrollment to the end of treatment at 8 weeks |
| Inflammatory Biomarkers: Advanced glycation end-products (AGEs) in 1 to 5 units. | The AGEs will assess with non-invasive fluorescence pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic Parameters: Body mass index-BMI (kg/m2). |
The BMI will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. |
| From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic Parameters: Basal metabolic rate (kcal). | The basal metabolic rate will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic Parameters: Fat mass (kg, %). | The fat mass will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic Parameters: Skeletal muscle mass (kg). | The skeletal muscle mass will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic Parameters: Waist-to-hip ratio. | The waist-to-hip ratio will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic Parameters: Handgrip strength (kg). | The handgrip strength will assess with dynamometry pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic Parameters: 30-second sit-to-stand test (n° of repetitions achieved). | The 30-second sit-to-stand test will assess with a 43 cm height chair pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic parameters: HRV, RMSSD and SDNN in (ms). | The heart rate variability will assess in 10 minutes with continuous recording of the resting electrocardiographic tracing pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic parameters: PNN50 (%). | The heart rate variability will assess in 10 minutes with continuous recording of the resting electrocardiographic tracing pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic parameters: Insuline (µIU/mL). | The fasting insulin by immunoassay will assess by a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic parameters: Glucose (mg/dL). | The fasting glucose by enzymatic method will assess by a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic parameters: HOMA-IR (index). | The HOMA-IR (calculated by fasting glucose x fasting insulin/405) will assess by a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic parameters: Lipid profile (mg/dL). | The lipid profile: total cholesterol, LDL, HDL and Triglycerides by enzymatic method will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic parameters: Liver profile (U/L). | The liver profile: ALS, AST, GGT: by enzymatic method will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| Cardiometabolic parameters: Blood pressure (mmHg) | The systolic and diastolic blood pressure will assess with a sphygmomanometer pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults. | From enrollment to the end of treatment at 8 weeks |
| 27456934 | Background | 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. |
| 30641865 | Background | 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. |
| 29206058 | Background | 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. |
| 33219913 | Background | 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. |
| 30695995 | Background | 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. |
| 30515938 | Background | 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. |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided