Antioxidant Capabilities, Antioxidant Status, Inflammation, Cardiometabolic Health Indicators, Inflammaging, Inflammation Biomarkers
Conditions
Keywords
Resveratrol, inflammation, inflammaging, antioxidant, cardiometabolic health, nutritional intervention
Brief summary
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTRES 120
This grape pomace bar have 120 mg of total polyphenols contents
DIETARY_SUPPLEMENTRES 250
This grape pomace bar is enriched with resveratrol until reach 250 mg of total polyphenols contents
DIETARY_SUPPLEMENTRES 500
This grape pomace bar is enriched with resveratrol until reach 500 mg of total polyphenols contents
Sponsors
Center for Research and Innovation Viña Concha y Toro
Universidad Católica del Maule
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This Clinical Trial will be carried out with 3 parallel arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Comunnity-dwelling persons. * Any ethnicity. * With willingness to consume the bar daily during the intervention period.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory biomarkers: Total plasma antioxidant capacity (µmol/L). | From enrollment to the end of treatment at 8 weeks | 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. |
| Inflammatory Biomarkers: Ultra-sensitivity CRP (mg/L). | From enrollment to the end of treatment at 8 weeks | 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. |
| Inflammatory Biomarkers: IL-6 (pg/mL). | From enrollment to the end of treatment at 8 weeks | 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. |
| Inflammatory Biomarkers: Plasma malondialdehyde (µmol/L). | From enrollment to the end of treatment at 8 weeks | 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. |
| Inflammatory Biomarkers: TNF-alfa (pg/mL). | From enrollment to the end of treatment at 8 weeks | 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. |
| Inflammatory Biomarkers: Advanced glycation end-products (AGEs) in 1 to 5 units. | From enrollment to the end of treatment at 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiometabolic Parameters: Body weight (kg). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic Parameters: Body mass index-BMI (kg/m2). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic Parameters: Basal metabolic rate (kcal). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic Parameters: Fat mass (kg, %). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic Parameters: Skeletal muscle mass (kg). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic Parameters: Waist-to-hip ratio. | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic Parameters: Handgrip strength (kg). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic Parameters: 30-second sit-to-stand test (n° of repetitions achieved). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic parameters: HRV, RMSSD and SDNN in (ms). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic parameters: PNN50 (%). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic parameters: Insuline (µIU/mL). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic parameters: Glucose (mg/dL). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic parameters: HOMA-IR (index). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic parameters: Lipid profile (mg/dL). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic parameters: Liver profile (U/L). | From enrollment to the end of treatment at 8 weeks | 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. |
| Cardiometabolic parameters: Blood pressure (mmHg) | From enrollment to the end of treatment at 8 weeks | 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. |
Countries
Chile
Contacts
CONTACTIleana González Bonet, Dr
CONTACTAndrea Herrera Santelices, Dr
STUDY_DIRECTORGerard Casaubon Cruzat
Center for Research and Innovation Viña Concha y Toro
Outcome results
None listed