NCT02042742

Brief Summary

A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI \<30 kg/m2. Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with 3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an 8 wk each phase with 4-wk rest period. Supplementation order was randomly assigned and the consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. The endothelial function parameters (brachial artery flow-mediated dilation (FMD), biochemical markers), inflammatory markers and nutritional status were evaluated before and after each phase. Previously a pilot study was completed with no placebo (n=30) to determinate the effective dose of Functional Supplement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

December 27, 2013

Last Update Submit

January 20, 2014

Conditions

Healthy

Keywords

Cross-over studiesAntioxidantsHydroxytyrosolPunicalaginTreatment outcomeInflammatory markersEndothelial functionHumansAdultsvolunteers

Outcome Measures

Primary Outcomes (1)

  • Change in the Inflammatory markers after 8 weeks treatment

    Inflammatory markers (Fibrinogen, gelsolin, thrombospondin, interleukin 6 and PCR) will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II

    0, 8, 12 and 20 weeks

Secondary Outcomes (8)

  • Change in Oxidative Stress Parameters

    0, 8, 12 and 20 weeks

  • Change in Glucose Metabolism

    0, 8, 12 and 20 weeks

  • Change in Lipid profile

    0, 8, 12 and 20 weeks

  • Change in Endothelial function

    0, 8, 12 and 20 weeks

  • Change in Coagulation markers

    0, 8, 12 and 20 weeks

  • +3 more secondary outcomes

Study Arms (2)

Antioxidant supplement

EXPERIMENTAL

Treatment consist of consuming 65g of punicalagin and 3,3g of hydroxytyrosol (plus 331,7g of maltodextrin) three times daily, during 8 weeks.

Dietary Supplement: punicalagin and hydroxytyrosol mixture

Control supplement

PLACEBO COMPARATOR

Treatment consist of consuming 400g of maltodextrin three times daily, during 8 weeks.

Dietary Supplement: Control supplement (maltodextrin)

Interventions

punicalagin and hydroxytyrosol mixtureDIETARY_SUPPLEMENT

Antioxidant Supplement (punicalagin and hydroxytyrosol mixture) During one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity.

Also known as: Punicalagin and hydroxytyrosol
Antioxidant supplement
Control supplement (maltodextrin)DIETARY_SUPPLEMENT

During one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity.

Also known as: Maltodextrin
Control supplement

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women from 45 to 75 years old;
  • Signed informed consent

You may not qualify if:

  • Individuals with cardiovascular risk factors on drug treatment (dyslipidemia, hypertension, Diabetes Mellitus);
  • Individuals with Metabolic Syndrome;
  • Individuals with familiar background of premature cardiovascular disease;
  • Individuals with BMI ≥ 30 kg/m2;
  • Women that still maintain your menstrual cycle;
  • Individuals with increased alcohol consumption 30g/day;
  • Individuals that stop smoking in the next 20 weeks (during the study);
  • Individuals that consume antioxidant supplement, drugs, ω-3 supplements, vitamins, minerals, prebiotics or/and probiotics;
  • Women that consume oral contraceptive;
  • Individuals with mental disease or low cognitive function;
  • Individuals with severe diseases (hepatic, kidney, cancer…);
  • Individuals with drugs or supplements consumption to weight lost;
  • Pregnant women or lactating;
  • Individuals with intensive physical activity;
  • Individuals with physical problems complying with the recommendations of physical activity and diet general recommendations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28061, Spain

Location

Related Links

MeSH Terms

Interventions

punicalagin3,4-dihydroxyphenylethanolmaltodextrin

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2013

First Posted

January 23, 2014

Study Start

April 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

ES(1)