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

Aging Clinical Trial

— HealthSpan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05202652
• Other study ID #: HealthSpan Trial
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: January 2022
• Source: National Hellenic Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 31, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Oxidative Stress
• Well Aging

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	Institute of Chemical Biology of National Hellenic Research Foundation	Athens	Attica

Sponsors (2)

Lead Sponsor	Collaborator
National Hellenic Research Foundation	Theracell Advanced Biotechnology

Country where clinical trial is conducted

Greece, 

References & Publications (13)

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. — View Citation

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

Beckman KB, Ames BN. The free radical theory of aging matures. Physiol Rev. 1998 Apr;78(2):547-81. Review. — View Citation

Beekman M, Blanché 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, Sørensen TI, Tan Q, Helmer Q, van den Akker EB, Deelen J, Martella F, Cordell HJ, Ayers KL, Vaupel JW, Törnwall 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. — View Citation

Catalgol B, Ziaja I, Breusing N, Jung T, Höhn 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. — View Citation

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. Epub 2005 Jan 20. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

López-Otín 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. Review. — View Citation

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. — View Citation

Weber D, Stuetz W, Toussaint O, Debacq-Chainiaux F, Dollé MET, Jansen E, Gonos ES, Franceschi C, Sikora E, Hervonen A, Breusing N, Sindlinger T, Moreno-Villanueva M, Bürkle 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Analysis adjusted for specific parameters to reveal potential confounders of the primary outcome of the intervention.	3 months
Secondary	Correlation of levels of oxidized proteins and measured 20S proteasome levels	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