NCT05202652

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: National Hellenic Research Foundation · Academic / Other
• Sex: All
• Age: 29 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Aging
• Well Aging
• Oxidative Stress

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-09-30
• Completion: 2021-08-31
• First posted: 2022-01-21
• Last updated: 2022-01-21

Locations

1 site across 1 country: Greece