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

Not Applicable

Completed

• Conditions: Well Aging; Oxidative Stress; Aging
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: HealthSpan

• Registration Number: NCT05202652
• Lead Sponsor: National Hellenic Research Foundation

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.

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 Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-09-30
• Study Completion: 2021-08-31
• Study First Submitted: 2021-12-22
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-08
• Last Update Submitted: 2022-01-08
• Study First Posted: 2022-01-21
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	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)
HealthSpan(HS) Group	HealthSpan	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.

Primary Outcome Measures

Name	Time	Method
Effect of the formulation on oxidized proteins' levels	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

Name	Time	Method
Correlation of levels of oxidized proteins and measured 20S proteasome levels	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.
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	Analysis adjusted for specific parameters to reveal potential confounders of the primary outcome of the intervention.

Trial Locations

Locations (1)

Institute of Chemical Biology of National Hellenic Research Foundation; 🇬🇷 Athens, Attica, Greece