NCT04436263

Brief Summary

The purpose of this study is to investigate the anti-platelet and anti-inflammatory properties of a winery by-products extract as well as to detect extract compounds and their metabolites in biological fluids. The study is a randomized, double-blind, crossover, placebo controlled postprandial study in healthy women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2021

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

1.4 years

First QC Date

June 15, 2020

Last Update Submit

June 17, 2020

Conditions

Platelet Aggregation and Inflammation

Keywords

winery by-productsnatural extractpostprandial studyplatelet aggregationanti-inflammatoryhealthy womenPlatelet-activating factor

Outcome Measures

Primary Outcomes (8)

  • Effect on platelet aggregation

    % Change of EC50 value of platelet aggregation against PAF

    Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions

  • Effect on platelet aggregation

    % Change of EC50 value of platelet aggregation against ADP

    Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions

  • Effect on platelet aggregation

    % Change of EC50 value of platelet aggregation against Collagen

    Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions

  • Effect on inflammatory markers

    Change in PAF biosynthetic enzymes activity (lyso-PAF AT)

    Change between timepoints (before meal consumption, 60min, 120min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions

  • Effect on inflammatory markers

    Change in PAF biosynthetic enzymes activity (PAF-CPT)

    Change between timepoints (before meal consumption, 60min, 120min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions

  • Effect on inflammatory markers

    Change in PAF levels Change in PAF degradation enzyme activity (Lp-PLA2) Change in PAF levels IL6

    Change between timepoints (before meal consumption, 60min, 120min, 180min, 240min, 360min) of the 6hour trial and between the two different interventions

  • Effect on inflammatory markers

    Change in PAF degradation enzyme activity (Lp-PLA2)

    Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions

  • Effect on inflammatory markers

    IL-6

    Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions

Secondary Outcomes (8)

  • Effect on classical biochemical markers

    Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions

  • Effect on classical biochemical markers

    Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions

  • Effect on classical biochemical markers

    Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions

  • Effect on classical biochemical markers

    Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions

  • Effect on classical biochemical markers

    Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions

  • +3 more secondary outcomes

Study Arms (2)

Supplement

EXPERIMENTAL

Ethanol-water extract of winery by-products

Behavioral: Supplement

Placebo

PLACEBO COMPARATOR

Maltodextrin-based placebo

Behavioral: Placebo

Interventions

SupplementBEHAVIORAL

A sufficient quantity of the winery by-products will be extracted on an industrial scale and capsules will be produced, each one containing 110mg of phenolic compounds (gallic acid equivalents).Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h

Supplement
PlaceboBEHAVIORAL

A look-alike placebo containing maltodextrin will be prepared.Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h

Placebo

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Females
  • BMI: 22-32 kg/m2

You may not qualify if:

  • Systematic medication
  • Chronic disease conditions
  • Specific dietary conditions (vegeterian, vegan...)
  • Eating disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition-Dietetics, Harokopio University

Athens, 17671, Greece

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Elizabeth Fragopoulou, PhD

CONTACT

2109549249efragop@hua.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Biological Chemistry

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 18, 2020

Study Start

January 20, 2020

Primary Completion

June 20, 2021

Study Completion

June 20, 2021

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)