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

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ClinicalTrials.gov Identifier: NCT05202652
Recruitment Status : Completed
First Posted : January 21, 2022
Last Update Posted : January 21, 2022
Sponsor:
Collaborator:
Theracell Advanced Biotechnology
Information provided by (Responsible Party):
National Hellenic Research Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aging Well Aging Oxidative Stress Dietary Supplement: HealthSpan Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   29 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05202652


Locations
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Greece
Institute of Chemical Biology of National Hellenic Research Foundation
Athens, Attica, Greece, 11635
Sponsors and Collaborators
National Hellenic Research Foundation
Theracell Advanced Biotechnology
Investigators
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Principal Investigator: Eftathios Gonos, PhD National Hellenic Research Foundation
More Information
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Publications:

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Responsible Party: National Hellenic Research Foundation
ClinicalTrials.gov Identifier: NCT05202652    
Other Study ID Numbers: HealthSpan Trial
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data of the study (statistical analysis, demographics) will be shared upon forthcoming publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will be available after publication (spring 2022)
Access Criteria: PIs affiliated with Research Institutions and Universities

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Hellenic Research Foundation:
nutraceuticals
dietary supplements
antioxidant defense
proteostasis
well-being