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Resveratrol Effects on Inflammatory Biomarkers and Cardiometabolic Parameters.

ConditionsInflammation BiomarkersCardiometabolic Health IndicatorsAntioxidant Status, InflammationAntioxidant CapabilitiesInflammaging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCenter for Research and Innovation Viña Concha y Toro

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Comunnity-dwelling persons.

Any ethnicity.

With willingness to consume the bar daily during the intervention period.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • RES 120

    Dietary supplement

    This grape pomace bar have 120 mg of total polyphenols contents

  • 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

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: RES 120Sham comparator 1 intervention
Group B: RES 250Experimental treatment 1 intervention
Group C: RES 500Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 8 weeks
2

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.

Time frame
From enrollment to the end of treatment at 8 weeks
3

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.

Time frame
From enrollment to the end of treatment at 8 weeks
4

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.

Time frame
From enrollment to the end of treatment at 8 weeks

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 8 weeks
2

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.

Time frame
From enrollment to the end of treatment at 8 weeks
3

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.

Time frame
From enrollment to the end of treatment at 8 weeks
4

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.

Time frame
From enrollment to the end of treatment at 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center for Research and Innovation Viña Concha y Toro

Lead sponsor

Universidad Católica del Maule

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: