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Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases

NCT06295913 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-02-12

No results posted yet for this study

Summary

The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging.

Conditions

Interventions

DIETARY_SUPPLEMENT

Group 1, hydroxytyrosol-rich extract capsule

Following a two-week washout period, the subjects will receive a bottle containing capsules (Group 1). Blood, urine, and fecal samples will be collected from each participant during their stay at the Human Nutrition Unit at the beginning and end of the study. Subjects will be instructed to refrain from consuming products rich in hydroxytyrosol (such as virgin olive oil and olives) and to maintain their usual dietary habits throughout the study. Additionally, olive oil (1L/week) will be provided to each volunteer that will consume during intervention study as the sole source of dietary fat, used for cooking, salad dressing, toasts, etc. in order to control the extra consumption of hydroxytyrosol apart from that provided by the capsule.

DIETARY_SUPPLEMENT

Group 2, capsule of placebo

Following a two-week washout period, the subjects will receive a bottle containing capsules (Placebo) (Group 2). Blood, urine, and fecal samples will be collected from each participant during their stay at the Human Nutrition Unit at the beginning and end of the study. Subjects will be instructed to refrain from consuming products rich in hydroxytyrosol (such as virgin olive oil and olives) and to maintain their usual dietary habits throughout the study. Additionally, olive oil (1L/week) will be provided to each volunteer that will consume during intervention study as the sole source of dietary fat, used for cooking, salad dressing, toasts, etc. in order to control the extra consumption of hydroxytyrosol.

Sponsors & Collaborators

  • Genosa I+D

    collaborator UNKNOWN

  • National Research Council, Spain

    lead OTHER_GOV

Principal Investigators

  • Raquel Mateos, PhD · Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-09-30
Completion
2024-12-20

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06295913 on ClinicalTrials.gov