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

NCT05202652 | Completed DMC

• 1 other identifier: HealthSpan Trial
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Well Aging; Oxidative Stress

Keywords

nutraceuticals; dietary supplements; antioxidant defense; proteostasis; well-being

Outcome Measures

Primary Outcomes (1)

• Effect of the formulation on oxidized proteins' levels

  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 Outcomes (2)

• 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

  3 months

• Correlation of levels of oxidized proteins and measured 20S proteasome levels

  3 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

HealthSpan(HS) Group

ACTIVE COMPARATOR

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

Interventions

HealthSpan 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.

HealthSpan(HS) Group

Placebo 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.

Control Group

Eligibility Criteria

• Age: 29 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Hellenic Research Foundation: lead
• Theracell Advanced Biotechnology: collaborator

Study Sites (1)

Institute of Chemical Biology of National Hellenic Research Foundation

Athens, Attica, 11635, Greece

Location

Related Publications (13)

• Beckman KB, Ames BN. The free radical theory of aging matures. Physiol Rev. 1998 Apr;78(2):547-81. doi: 10.1152/physrev.1998.78.2.547.

  PMID: 9562038 BACKGROUND

• Beekman M, Blanche H, Perola M, Hervonen A, Bezrukov V, Sikora E, Flachsbart F, Christiansen L, De Craen AJ, Kirkwood TB, Rea IM, Poulain M, Robine JM, Valensin S, Stazi MA, Passarino G, Deiana L, Gonos ES, Paternoster L, Sorensen TI, Tan Q, Helmer Q, van den Akker EB, Deelen J, Martella F, Cordell HJ, Ayers KL, Vaupel JW, Tornwall O, Johnson TE, Schreiber S, Lathrop M, Skytthe A, Westendorp RG, Christensen K, Gampe J, Nebel A, Houwing-Duistermaat JJ, Slagboom PE, Franceschi C; GEHA consortium. Genome-wide linkage analysis for human longevity: Genetics of Healthy Aging Study. Aging Cell. 2013 Apr;12(2):184-93. doi: 10.1111/acel.12039. Epub 2013 Feb 6.

  PMID: 23286790 BACKGROUND

• Catalgol B, Ziaja I, Breusing N, Jung T, Hohn A, Alpertunga B, Schroeder P, Chondrogianni N, Gonos ES, Petropoulos I, Friguet B, Klotz LO, Krutmann J, Grune T. The proteasome is an integral part of solar ultraviolet a radiation-induced gene expression. J Biol Chem. 2009 Oct 30;284(44):30076-86. doi: 10.1074/jbc.M109.044503. Epub 2009 Aug 18.

  PMID: 19690165 BACKGROUND

• 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.

  PMID: 15661736 BACKGROUND

• Gonos E. Proteasome activation as a novel anti-aging strategy. Free Radic Biol Med. 2014 Oct;75 Suppl 1:S7. doi: 10.1016/j.freeradbiomed.2014.10.842. Epub 2014 Dec 10.

  PMID: 26461417 BACKGROUND

• 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.

  PMID: 28034832 BACKGROUND

• Weber D, Stuetz W, Toussaint O, Debacq-Chainiaux F, Dolle MET, Jansen E, Gonos ES, Franceschi C, Sikora E, Hervonen A, Breusing N, Sindlinger T, Moreno-Villanueva M, Burkle A, Grune T. Associations between Specific Redox Biomarkers and Age in a Large European Cohort: The MARK-AGE Project. Oxid Med Cell Longev. 2017;2017:1401452. doi: 10.1155/2017/1401452. Epub 2017 Jul 19.

  PMID: 28804532 BACKGROUND

• 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.

  PMID: 24342354 BACKGROUND

• Lopez-Otin C, Blasco MA, Partridge L, Serrano M, Kroemer G. The hallmarks of aging. Cell. 2013 Jun 6;153(6):1194-217. doi: 10.1016/j.cell.2013.05.039.

  PMID: 23746838 BACKGROUND

• Aunan JR, Watson MM, Hagland HR, Soreide K. Molecular and biological hallmarks of ageing. Br J Surg. 2016 Jan;103(2):e29-46. doi: 10.1002/bjs.10053.

  PMID: 26771470 BACKGROUND

• 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.

  PMID: 25540941 BACKGROUND

• 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.

  PMID: 29779015 BACKGROUND

• 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.

  PMID: 29765333 BACKGROUND

Study Officials

• Eftathios Gonos, PhD

  National Hellenic Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 21, 2022
• Study Start: September 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: August 31, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available after publication (spring 2022)
• Access Criteria: PIs affiliated with Research Institutions and Universities

Locations

GR (1)