Testing a red orange extract as a food supplement to improve antioxidant defense and quality of life in older adults
- Conditions
- Healthy ageing in older adults aged between 45 and 60 years oldNot Applicable
- Registration Number
- ISRCTN11550896
- Lead Sponsor
- BIONAP srl
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36296919/ (added 07/11/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
1. Subjects who do not fit the inclusion criteria
2. Subjects <45 and >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Systemic antioxidants pool assessed by the following measures at baseline and after 2 and 8 weeks of product intake:<br> 1. The concentration of glutathione in erythrocytes measured using GSH+GSSG/GSH Assay colorimetric Kit from Abcam (ref. no. ab239709)<br> 2. d-ROMS hematic concentration measured using a FRAS 5 device (H&D srl, Parma, Italy)<br>
- Secondary Outcome Measures
Name Time Method <br> Measures assessed at baseline and after 2 and 8 weeks of product intake:<br> 1. Anti-inflammatory activity determined by TNF-alpha levels measured using sandwich ELISA from Abcam (ref. no. ab46087)<br> 2. Quality of life in male subjects measured using the Short Form quality of life (SF-36 QoL) questionnaire<br> 3. Menopausal symptoms in female subjects measured using the Menopause Rating Scale (MRS)<br> 4. Safety of use by analysis of blood and urine parameters measured using the current protocol of accredited medical analysis laboratory<br>