Evaluation of Anti-oxidant, Anti-aging and Wellbeing Effects of a Novel Nutraceutical Formulation (HealthSpan) (HealthSpan)

January 8, 2022 updated by: National Hellenic Research Foundation

A Randomized, Placebo-controlled Prospective Trial for the Evaluation of Anti-oxidant, Anti-aging and Wellbeing Effects of a Novel Nutraceutical Formulation (HealthSpan)

The study was designed as a randomized, placebo-controlled trial with follow-up at 3 months. The study is in accordance with the Declaration of Helsinki and was approved by the Institutional Bioethical Committee of the National Hellenic Research Foundation. All the study participants received informative material, filled a questionnaire regarding the self-assessment of their health status and nutritional habits, and signed their written informed consent. In total, excluding the participants that did not return for the follow-up (dropouts), 122 apparently healthy volunteers of age 29-85 were followed, with 43 of them being randomly assigned in the placebo subgroup and 79 receiving the composition of the present invention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was designed as a randomized, placebo-controlled trial with follow-up at 3 months. The study is in accordance with the Declaration of Helsinki and was approved by the Institutional Bioethical Committee of the National Hellenic Research Foundation. All the study participants received informative material, filled a questionnaire regarding the self-assessment of their health status and nutritional habits, and signed their written informed consent. Patients eligible for the inclusion criteria were randomized into two groups: the group of healthy adult volunteers that received a capsule with the active formulation and those the received the placebo (a capsule with only the carrier substance magnesium stearate) In total, excluding the participants that did not return for the follow-up (dropouts), 122 apparently healthy volunteers of age 29-85 were followed, with 43 of them being randomly assigned in the placebo subgroup and 79 receiving the composition of the present invention.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11635
        • Institute of Chemical Biology of National Hellenic Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

29 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • residence in the Athens metropolitan area
  • age 29-85

Exclusion Criteria:

  • diagnosed cancer, subjects that were under chemotherapy, therapy with biological factors and radiotherapy
  • use of nutritional supplements during the clinical trial period
  • diagnosed autoimmune diseases or other chronic diseases
  • subjects that had lived less than 50% of their life in the country that is their current residence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
The control group received a three month supply of 90 vegetal capsules of hydroxypropyl methylcellulose, each of them containing 455mg of the carrier substance (magnesium stearate)
Dietary supplement: Placebo
The intervention was conducted on a group of healthy volunteers of age 29-85 with a once-daily administration of the placebo, for three consecutive months.
Active Comparator: HealthSpan(HS) Group
The HS group received a three month supply of 90 vegetal capsules of hydroxypropyl methylcellulose, each of them containing the 455mg of the mixture of the active compounds along with the carrier.
Dietary supplement: HealthSpan
The intervention was conducted on a group of healthy volunteers of age 29-85 with a once-daily administration of the oral capsule containing the active ingredients, for three consecutive months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of the formulation on oxidized proteins' levels
Time Frame: 3 months
Oxidative stress states can be indicative of an impaired antioxidant defense. The study focused on the assessment of oxidative stress status by the protein carbonyls' levels before and after the intervention.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the effect of the formulation on oxidized proteins' levels adjusted for sex, age, and lifestyle habits of the sample as assessed in the study's questionnaire
Time Frame: 3 months
Analysis adjusted for specific parameters to reveal potential confounders of the primary outcome of the intervention.
3 months
Correlation of levels of oxidized proteins and measured 20S proteasome levels
Time Frame: 3 months
Oxidized proteins are the preferred substrates for enzymatic degradation by the proteasome. The study also investigated the interrelation between those two biomarkers in order to assess the effect of the intervention in proteasomal proteolysis.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Hellenic Research Foundation

Collaborators

Theracell Advanced Biotechnology

Investigators

  • Principal Investigator: Eftathios Gonos, PhD, National Hellenic Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

January 8, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 8, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HealthSpan Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data of the study (statistical analysis, demographics) will be shared upon forthcoming publication.

IPD Sharing Time Frame

Data will be available after publication (spring 2022)

IPD Sharing Access Criteria

PIs affiliated with Research Institutions and Universities

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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