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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 This study will focus on the development of a specific dietary approach through an E-Health dietary service, associated or not to nutraceutical food supplements intake, to modulate the oxidative stress, inflammageing and gut microflora in the elderly people.
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 |
|---|---|---|---|
| Diet advices | Active Comparator | will receive the Optimal Diet for Elderly |
|
| Diet advices + VSL-3 | Experimental | will receive the Optimal Diet for Elderly + VSL#3® probiotic blend |
|
| Diet advices + 5203-L | Experimental | will receive the Optimal Diet for Elderly + AISA-5203-L fruit extracted terpene |
|
| Diet advices + Argan oil | Experimental | will receive the Optimal Diet for Elderly + Argan oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSL#3® probiotic blend | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein) | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammageing status: WBC, hemoglobin, ERS, fibrinogen, total cholesterol, triglycerides, insulin, glucose, (and HOMA Index), interleukin-6, TNFα, IL-10, TGF1, IGF-1, adiponectin, lectin, Homocysteine, folic acid and vitamin B12, calprotectin | 2 months | |
| Oxidative stress: plasma total antioxidant capacity by TEAA (Trolox Equivalent Antioxidant Activity), glutathione level, the superoxide dismutase, the glutathione peroxidase, the glutathione reductase and the catalase activities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle BOURDEL-MARCHASSON, Professor | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pôle de gerontology Clinique Hôpital Xavier Arnozan , University Hospital, Bordeaux | Pessac | 33600 | France |
| 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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| AISA-5203-L fruit extracted terpene | Dietary Supplement | 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 |
|
| Optimal Diet | Behavioral | a dietician will train each subject (or the caregiver) to use the personalized diet on web platform. |
|
| 2 months |
| Gut microbiota: expression of 16S ribosomal RNA in bacterial groups from faeces. Ratio between lactobacilli and clostridia bacteria. Real time PCR and PCR DGGE | 2 months |
| Quality of life: SF-36, GHQ, and daily VAS, ECOG performance status, IADL, Speilbeger Anxiety Scale, CES-D scale | 2 months |
| Physical performance status (SPPB), muscle function (hand-grip dynamometry), and physical activity level (IPAQ) | 2 months |
| Compliance to the web diet advices and to the nutraceutical supplement intake (daily VAS) | 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. |
| ID | Term |
|---|---|
| C555574 | argan oil |
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