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

NCT ID: NCT05202652

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aging Well Aging Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type ACTIVE_COMPARATOR

HealthSpan

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

29 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Theracell Advanced Biotechnology

UNKNOWN

Sponsor Role collaborator

National Hellenic Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eftathios Gonos, PhD

Role: PRINCIPAL_INVESTIGATOR

National Hellenic Research Foundation

Locations

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Institute of Chemical Biology of National Hellenic Research Foundation

Athens, Attica, Greece

Site Status

Countries

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Greece

References

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Chondrogianni N, Tzavelas C, Pemberton AJ, Nezis IP, Rivett AJ, Gonos ES. Overexpression of proteasome beta5 assembled subunit increases the amount of proteasome and confers ameliorated response to oxidative stress and higher survival rates. J Biol Chem. 2005 Mar 25;280(12):11840-50. doi: 10.1074/jbc.M413007200. Epub 2005 Jan 20.

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Reference Type BACKGROUND
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Kapetanou M, Chondrogianni N, Petrakis S, Koliakos G, Gonos ES. Proteasome activation enhances stemness and lifespan of human mesenchymal stem cells. Free Radic Biol Med. 2017 Feb;103:226-235. doi: 10.1016/j.freeradbiomed.2016.12.035. Epub 2016 Dec 27.

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Santoro A, Pini E, Scurti M, Palmas G, Berendsen A, Brzozowska A, Pietruszka B, Szczecinska A, Cano N, Meunier N, de Groot CP, Feskens E, Fairweather-Tait S, Salvioli S, Capri M, Brigidi P, Franceschi C; NU-AGE Consortium. Combating inflammaging through a Mediterranean whole diet approach: the NU-AGE project's conceptual framework and design. Mech Ageing Dev. 2014 Mar-Apr;136-137:3-13. doi: 10.1016/j.mad.2013.12.001. Epub 2013 Dec 14.

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Chondrogianni N, Voutetakis K, Kapetanou M, Delitsikou V, Papaevgeniou N, Sakellari M, Lefaki M, Filippopoulou K, Gonos ES. Proteasome activation: An innovative promising approach for delaying aging and retarding age-related diseases. Ageing Res Rev. 2015 Sep;23(Pt A):37-55. doi: 10.1016/j.arr.2014.12.003. Epub 2014 Dec 23.

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Gonos ES, Kapetanou M, Sereikaite J, Bartosz G, Naparlo K, Grzesik M, Sadowska-Bartosz I. Origin and pathophysiology of protein carbonylation, nitration and chlorination in age-related brain diseases and aging. Aging (Albany NY). 2018 May 17;10(5):868-901. doi: 10.18632/aging.101450.

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Athanasopoulou S, Chondrogianni N, Santoro A, Asimaki K, Delitsikou V, Voutetakis K, Fabbri C, Pietruszka B, Kaluza J, Franceschi C, Gonos ES. Beneficial Effects of Elderly Tailored Mediterranean Diet on the Proteasomal Proteolysis. Front Physiol. 2018 May 1;9:457. doi: 10.3389/fphys.2018.00457. eCollection 2018.

Reference Type BACKGROUND
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Other Identifiers

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HealthSpan Trial

Identifier Type: -

Identifier Source: org_study_id

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