Evaluation of Anti-oxidant, Anti-aging and Wellbeing Effects of a Novel Nutraceutical Formulation (HealthSpan) (HealthSpan)
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|ClinicalTrials.gov Identifier: NCT05202652|
Recruitment Status : Completed
First Posted : January 21, 2022
Last Update Posted : January 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Aging Well Aging Oxidative Stress||Dietary Supplement: HealthSpan Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 :||September 1, 2019|
|Actual Primary Completion Date :||September 30, 2020|
|Actual Study Completion Date :||August 31, 2021|
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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05202652
|Institute of Chemical Biology of National Hellenic Research Foundation|
|Athens, Attica, Greece, 11635|
|Principal Investigator:||Eftathios Gonos, PhD||National Hellenic Research Foundation|