Healthy ageing in older adults aged between 45 and 60 years old Not Applicable
Conditions
Interventions
while the placebo intervention was maltodextrin. Both the active and the placebo products were used as follows: one capsule per day intake at breakfast for 8 weeks.
Half of the test su
Sponsors
BIONAP srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men (50%) and women (50%) aged 45-60 years old 2. Subjects with menopausal symptoms (only for women) 3. Subjects naïve to treatment and food supplements that can interfere with the study treatment for the previous 1 month 4. Not used topical products/food supplements with similar effects to the product being tested (antioxidant) during the entire study period 5. Subjects registered with health social security or health social insurance 6. Subjects reading, understanding and signed approval of the informative consent 7. Not vegetarian 8. Subjects who will continue their normal lifestyle 9. Healthy subjects without clinical illness diagnosed with relevant diseases of the gastrointestinal system or visceral motility 10. Not pregnant 11. Non-smokers 12. Subjects available and willing to follow the procedures of the study protocol 13. Subjects able to understand the language used in the investigation centre and the information given
Exclusion criteria
Exclusion criteria: 1. Subjects who do not fit the inclusion criteria 2. Subjects 60 years old 3. Clinical history of relevant present disorders or administration of drugs/food supplements that can potentially interfere with the treatment under study 4. Lack of compliance defined as not using the correct dose or placebo for >1 week, and the inability to give informed consent 5. Subjects who have changed their diet significantly or have been placed on weight reduction products 6. Smokers, obese subjects 7. Subjects changing their eating habits within the 2 weeks previous to the screening 8. Pregnancy or subjects planning a pregnancy 9. Breastfeeding 10. Subjects with a history of drug, alcohol, and other substance abuse 11. Subjects planning to change their lifestyle or physical activity 12. Known food intolerance or food allergy 13. Subjects involved in a clinical or food study within the previous month 14. Subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure) 15. Subjects with a history of paralysis or cerebral vascular accident 16. Subjects with active cancers or on chemotherapy 17. Subjects who have been under diuretics for the previous one months 18. Other factors that limit their ability to cooperate during the study 19. Subjects deprived of freedom by administrative or legal decision or under guardianship 20. Subjects not able to be contacted in case of emergency 21. Subjects planning a hospitalisation during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic antioxidants pool assessed by the following measures at baseline and after 2 and 8 weeks of product intake: 1. The concentration of glutathione in erythrocytes measured using GSH+GSSG/GSH Assay colorimetric Kit from Abcam (ref. no. ab239709) 2. d-ROMS hematic concentration measured using a FRAS 5 device (H&D srl, Parma, Italy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measures assessed at baseline and after 2 and 8 weeks of product intake: 1. Anti-inflammatory activity determined by TNF-alpha levels measured using sandwich ELISA from Abcam (ref. no. ab46087) 2. Quality of life in male subjects measured using the Short Form quality of life (SF-36 QoL) questionnaire 3. Menopausal symptoms in female subjects measured using the Menopause Rating Scale (MRS) 4. Safety of use by analysis of blood and urine parameters measured using the current protocol of accredited medical analysis laboratory | — |
Countries
Italy
Outcome results
None listed