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

National Hellenic Research Foundation

Status: Completed

Conditions: Aging; Well Aging; Oxidative Stress

Treatments: Dietary Supplement: Placebo; Dietary Supplement: HealthSpan

Study type: Interventional

Funder types: Other

Identifiers

NCT05202652

HealthSpan Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 29 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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122 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: Placebo

HealthSpan(HS) Group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: HealthSpan