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Ageing of the population is a major event in the world. Gerontological/geriatric literature unanimously indicate that physical exercise and diet are at present the two available fundamental approaches to contrast/prevent most of the age associated alterations. In the elderly the inflammageing, the oxidative stress and the alteration of the intestinal microbiota can be influenced by nutritional status and possibly corrected by an appropriate dietetic intervention:
Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve the quality of individual diet for specific needs
Ageing of the population is a major event in the world. Gerontological/geriatric literature unanimously indicate that physical exercise and diet are at present the two available fundamental approaches to contrast/prevent most of the age associated alterations. In the elderly the inflammageing, the oxidative stress and the alteration of the intestinal microbiota can be influenced by nutritional status and possibly corrected by an appropriate dietetic intervention:
Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve the quality of individual diet for specific needs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimal Diet | Active Comparator | Diet advices will receive the Optimal Diet for Elderly |
|
| VSL#3 | Experimental | Diet advices + VSL-3: will receive the Optimal Diet for Elderly + VSL#3® probiotic blend |
|
| AISA-5203-L | Experimental | Diet advices + 5203-L: will receive the Optimal Diet for Elderly + AISA-5203-L fruit extracted terpene |
|
| Argan oil | Experimental | Diet advices + Argan oil: will receive the Optimal Diet for Elderly + Argan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimal Diet | Behavioral | a dietician will train each subject (or the caregiver) to use the personalized diet on web platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk) | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammageing status as measure of ageing-associated inflammatory processes | WBC, hemoglobin, erythrocyte sedimentation rate, fibrinogen, total cholesterol, triglycerides, insulin, glucose, IL-6, TNFα, IL-10, TGF-1, IGF-1, adiponectin, leptin, homocysteine, folic acid and vitamin B12 | 2 months |
| Oxidative stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11053678 | Background | Franceschi C, Valensin S, Bonafe M, Paolisso G, Yashin AI, Monti D, De Benedictis G. The network and the remodeling theories of aging: historical background and new perspectives. Exp Gerontol. 2000 Sep;35(6-7):879-96. doi: 10.1016/s0531-5565(00)00172-8. | |
| 11036829 | Background | Wener MH, Daum PR, McQuillan GM. The influence of age, sex, and race on the upper reference limit of serum C-reactive protein concentration. J Rheumatol. 2000 Oct;27(10):2351-9. |
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| ID | Term |
|---|---|
| C555574 | argan oil |
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| VSL#3® | Dietary Supplement | probiotic blend Product should be administrated orally, 2 capsules b.i.d. on an empty stomach (at least 30 min. before lunch and dinner) with a glass of water |
|
| AISA-5203-L | Dietary Supplement | fruit extracted terpene Product should be administrated orally, the dosage depending from the body weight of the subject enrolled in the study as already stated : 1-2 pills three times a day with a meal and a large glass of water |
|
| Argan oil | Dietary Supplement | Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water |
|
Plasma total antioxidant capacity by TEAA (Trolox Equivalent Antioxidant Activity), glutathione , superoxide dismutase, glutathione peroxidase, glutathione reductase, catalase activities |
| 2 months |
| Gut micobiota | Expression of 16S ribosomal RNA bacterial groups from feces by RT-PCR. Ratio between lactobacilli and clostridia bacteria as measure of impact of personalized nutrition with and without nutraceuticals on gut microbiota. | 2 months |
| Quality of life (QoL) | Daily visual analogue scale, SF-36 and General Health Questionnaire (GHQ) as direct measures of QoL. ECOG performance status, IADL, Spielberger Anxiety Index (SAI), and CED-D scale as indirect measures of quality of life. | 2 months |
| Physical performance status | Short physical performance battery (SBBP), muscle function (hand-grip dynamometry, and physical activity level (IPAQ). | 2 months |
| Compliance | Daily visual analogue scales as measures of compliance to web diet advices and to the nutraceutical intake. | 2 months |
| 8616412 | Background | Mendall MA, Patel P, Ballam L, Strachan D, Northfield TC. C reactive protein and its relation to cardiovascular risk factors: a population based cross sectional study. BMJ. 1996 Apr 27;312(7038):1061-5. doi: 10.1136/bmj.312.7038.1061. |
| 15899961 | Background | Devaraj S, O'Keefe G, Jialal I. Defining the proinflammatory phenotype using high sensitive C-reactive protein levels as the biomarker. J Clin Endocrinol Metab. 2005 Aug;90(8):4549-54. doi: 10.1210/jc.2005-0069. Epub 2005 May 17. |
| 26249791 | Derived | Ostan R, Bene MC, Spazzafumo L, Pinto A, Donini LM, Pryen F, Charrouf Z, Valentini L, Lochs H, Bourdel-Marchasson I, Blanc-Bisson C, Buccolini F, Brigidi P, Franceschi C, d'Alessio PA. Impact of diet and nutraceutical supplementation on inflammation in elderly people. Results from the RISTOMED study, an open-label randomized control trial. Clin Nutr. 2016 Aug;35(4):812-8. doi: 10.1016/j.clnu.2015.06.010. Epub 2015 Jul 15. |
| 25453395 | Derived | Valentini L, Pinto A, Bourdel-Marchasson I, Ostan R, Brigidi P, Turroni S, Hrelia S, Hrelia P, Bereswill S, Fischer A, Leoncini E, Malaguti M, Blanc-Bisson C, Durrieu J, Spazzafumo L, Buccolini F, Pryen F, Donini LM, Franceschi C, Lochs H. Impact of personalized diet and probiotic supplementation on inflammation, nutritional parameters and intestinal microbiota - The "RISTOMED project": Randomized controlled trial in healthy older people. Clin Nutr. 2015 Aug;34(4):593-602. doi: 10.1016/j.clnu.2014.09.023. Epub 2014 Oct 8. |