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| Name | Class |
|---|---|
| Biostile | INDUSTRY |
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The use of food supplements with the aim of increasing longevity in the general population is rapidly increasing, while high-quality clinical evidence on the efficacy of comprehensive formulations and their impact on biomarkers of aging is lacking. The present clinical trial will evaluate the effects of selected morning- and evening-speciffic dietary supplement on longevity biomarkers in a selected population of healthy adults of both sexes between the ages of 50 and 70 and compare it to placebo. The main questions it answers are: Does the 6-month use of the longevity supplement impact the 6-months change in different markers for measuring biological age compared to placebo? The study will involve 60 subjects, of whom 30 will consume the morning- and evening-speciffic longevity food supplements and 30 will consume a placebo. The study will last 6 months. The subjects will will visit the Faculty four times: at the beginning of the study (background measurement), after one, three and six months of consuming the dietary supplement or placebo. At each visit, subjects will undergo anthropometric measurements, blood pressure measurements, and blood samples will be taken to determine baseline haematocrite, albumin, creatinine, alcaline phosphatase, lipid profile, glucose concentration, inflammatory parameters, antioxidant potential, liver enzymes, and expression of genes for autophagy and oxidative stress. Subjects will also complete 3-day food diaries and questionnaires on general health, physical activity, and quality of sleep and life.
On baseline and final (six months) measurements resting metabolic rate and DXA body composition measurements will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morning- and evening-speciffic longevity food supplement | Experimental | 6-month daily consumption of 1 morning-specific capsule and 1 evening-specific capsule. |
|
| Control | Placebo Comparator | 6-month daily consumption of 2 capsules of maltodextrin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morning- and evening-specific compound food supplement | Dietary Supplement | 1 capsule of morning-speciffic supplement per day after breakfast with glass of water and 1 capsule of evening-speciffic supplement per day after dinner with glass of water for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine | Creatinine levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Albumin | Albumin levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Glucose | Glucose levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| CRP | CRP levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Lymphocyte percent | Lymphocyte percent will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Mean cell volume | Mean cell volume will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Red cell distribution width | Red cell distribution width will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol | Total cholesterol will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| LDL cholesterol |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass | Body mass [kg] will be measured with body scale at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Blood pressure |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University pf Primorska, Faculty of Health Sciences | Izola | 6310 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37918922 | Background | Ruan Z, Li D, Huang D, Liang M, Xu Y, Qiu Z, Chen X. Relationship between an ageing measure and chronic obstructive pulmonary disease, lung function: a cross-sectional study of NHANES, 2007-2010. BMJ Open. 2023 Nov 2;13(11):e076746. doi: 10.1136/bmjopen-2023-076746. | |
| 2748771 | Background | Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. |
| Label | URL |
|---|---|
| Description WHO5 Slovenian translation | View source |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Control | Dietary Supplement | 2 capsules per day at breakfast with glass of water for 6 months. |
|
| From enrolment to the end of last measurement at 6 months. |
| Alcaline phosphatase | Alcaline phosphatase will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| White blood cell count | White blood cell count will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| PhenoAge | PhenoAge will be calculated from albumin, creatinine, glucose, lymphocyte percent, mean cell volume, red cell distribution width, alcaline phosphatase, white blood cell count and cronological age at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
LDL cholesterol will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
| From enrolment to the end of last measurement at 6 months. |
| HDL cholesterol | HDL cholesterol will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Triacylglycerols | Triacylglycerols levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Antioxidative potential | Antioxidative potential will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Alanine aminotransferase (ALT) | ALT will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Aspartate aminotransferase (AST) | AST will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Interleukine-6 (IL-6) | IL-6 will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Tumor necrosis factor alpha (TNF-alpha) | TNF-alpha will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| NAD+/NADH | NAD+/NADH ratio will be measured from venous blood at baseline and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Sleep quality | Sleep quality will be assessed with THe Pittsburgh Sleep Quality Index questionnaire (Buysse et al., 1989) at baseline, after 1, 3 and 6 months of daily dietary supplements use. PSQI is a self-report questionnaire that evaluates sleep quality over the past month, using 19 items to generate 7 component scores (0-3 each) and a global score (0-21). A total global score >5 indicates poor sleep quality. Higher scores signify more severe sleep disturbances. | From enrolment to the end of last measurement at 6 months. |
| World Health Organization-FIve Well-Being Index | Quality of life will be assessed with World Health Organization-FIve Well-Being Index (WHO5 questionnaire, Slovenian translation, WHO, 2024) at baseline, after 1, 3 and 6 months of daily dietary supplements use. The WHO-5 Well-Being Index is a 5-item self-report questionnaire measuring mental well-being over the past two weeks, scored on a 0-25 scale that is multiplied by 4 for a 0-100 range. Higher scores indicate better well-being, while a score 50 or less suggests poor well-being. | From enrolment to the end of last measurement at 6 months. |
| BMAL1 gene expression | BMAL1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| ATG1 gene expression | ATG1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| SD1 gene expression | SD1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| mTOR gene expression | mTOR gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| SIRT1 gene expression | SIRT1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Glutation reductase gene expression | Glutation reductase gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
Systolic and diastolic blood pressures [mmHg] will be measured at baseline, after 1, 3 and 6 months of daily dietary supplements use.
| From enrolment to the end of last measurement at 6 months. |
| Physical activity level | Physical activity level will be assessed with International Physical Activity Questionnaire (IPAQ) at baseline, after 1, 3 and 6 months of daily dietary supplements use. IPAQ quantifies physical activity into MET-minutes/week (walking=3.3, moderate=4.0, vigorous=8.0 METs). High activity is more than 3000 MET-min/week, Moderate is between 600 MET-min/week and 3000 MET-min/week, and Low is less than 600 MET-min/week. | From enrolment to the end of last measurement at 6 months. |
| Body height | Body height [m] will be measured with stadiometer at baseline. | From enrolment to the end of last measurement at 6 months. |
| Body mass index | Body mass index (BMI, [kg/m2]) will be calculated from body mass (BM, [kg]) and body height (BH, [m]) using the standard equation BMI = BM/(BH x BH) at baseline, after 1, 3 and 6 months of daily dietary supplements use. BH data measured at baseline will be used throughout the study while BM will be measured at each measurement as specified. | From enrolment to the end of last measurement at 6 months. |
| Bioimpedance analysis | Resistance and reactance will be measured with Bioelectrical Impedance Analysis (BIA) at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Body fat percentage | Body fat percentage will be calculated from resistance and reactance data, determined with BIA at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Fat free mass | Fat free mass will be calculated from resistance and reactance data, determined with BIA at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Phase angle | Phase angle will be calculated from resistance and reactance data, determined with BIA at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Muscle mass | Muscle mass will be calculated from resistance and reactance data, determined with BIA at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Metabolic age | Metabolic age will be calculated from resistance and reactance data with BIA software at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Visceral fat rating | Visceral fat rating will be calculated from resistance and reactance datawith BIA software at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Waist circumference | Waist circumference (WC, [cm]) will be measured with measuring tape half way between the lowest rib and top of the hip bone at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| Hip circumference | Hip circumference (HC, [cm]) will be measured with measuring tape half way between the lowest rib and top of the hip bone at baseline, after 1, 3 and 6 months of daily dietary supplements use. | From enrolment to the end of last measurement at 6 months. |
| 15380917 | Background | Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004. |
| D001523 |
| Mental Disorders |