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Completed

NCT Number: NCT05202652

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

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.

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Key information

Conditions

Aging Oxidative Stress Well Aging

Age range

29 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Chemical Biology of National Hellenic Research Foundation

Athens, Attica, 11635, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Hellenic Research Foundation

Other

Collaborators

  • Theracell Advanced Biotechnology

Registry information

Official study title

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

Acronym: HealthSpan

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 21, 2022
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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