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

Sponsor

National Hellenic Research Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT05202652

Collaborator

Theracell Advanced Biotechnology (Other)

122

Enrollment

Location

Arms

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Sep 1, 2019

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

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.

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

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

29 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Institute of Chemical Biology of National Hellenic Research Foundation	Athens	Attica	Greece	11635

Sponsors and Collaborators

National Hellenic Research Foundation
Theracell Advanced Biotechnology

Investigators

Principal Investigator: Eftathios Gonos, PhD, National Hellenic Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

National Hellenic Research Foundation

ClinicalTrials.gov Identifier:

NCT05202652

Other Study ID Numbers:

HealthSpan Trial

First Posted:

Jan 21, 2022

Last Update Posted:

Jan 21, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Hellenic Research Foundation

Study Results

No Results Posted as of Jan 21, 2022