Aging, Oxidative Stress, Well Aging
Conditions
Keywords
nutraceuticals, dietary supplements, antioxidant defense, proteostasis, well-being
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
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.
DIETARY_SUPPLEMENTHealthSpan
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.
Sponsors
Theracell Advanced Biotechnology
National Hellenic Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
29 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Greece
Outcome results
None listed