Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
48 participants
INTERVENTIONAL
2009-10-31
2011-06-30
Brief Summary
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Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve the quality of individual diet for specific needs
Detailed Description
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Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve the quality of individual diet for specific needs
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Optimal Diet
Diet advices will receive the Optimal Diet for Elderly
Optimal Diet
a dietician will train each subject (or the caregiver) to use the personalized diet on web platform
VSL#3
Diet advices + VSL-3: will receive the Optimal Diet for Elderly + VSL#3® probiotic blend
VSL#3®
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
Diet advices + 5203-L: will receive the Optimal Diet for Elderly + AISA-5203-L fruit extracted terpene
AISA-5203-L
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
Diet advices + Argan oil: will receive the Optimal Diet for Elderly + Argan
Argan oil
Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water
Interventions
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Optimal Diet
a dietician will train each subject (or the caregiver) to use the personalized diet on web platform
VSL#3®
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
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
Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index: 22-30 kg/m2
* ECOG Performance status: WHO performance score 0 to 2
* Absence of known diseases and/or abnormalities of haematological parameters (haematological, inflammatory, metabolic, hepatic and renal diseases)
* The subjects must be able to comply with management of nutraceutical products and with scheduled follow-up
* The subjects must be able to use the computer and to access to the web, by themselves or with the help of a caregiver
Exclusion Criteria
* Geriatric anorexia \[less than 2 full meals per day and /or less than one serving of dairy products (milk, cheese, yogurt) per day or two or more servings of legumes or eggs per week or one serving of meat, fish or poultry every day\]
* Weight loss \> 5% in the last month
* Previous antibiotic treatment within 4 months
* Active infection requiring per OS or IV antibiotics, including active tuberculosis, known and declared HIV, HCV
* Constipation and/or abdominal pain/discomfort that require dietary supplements or medical therapy
* Gastric disease that requires medical therapy (e.g. gastric secretion inhibitory drugs)
* Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis, diverticulosis, diverticulitis)
* Diabetes mellitus
* Dislipidemia and/or any metabolic disease that requires medical or dietetic treatment
* Myocardial infarction within 6 months prior to study entry, congestive heart disease, uncontrolled cardiac insufficiency, and any current grade 3 or 4 cardio-vascular disorder despite treatment
* Current history of neoplasm except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix and except for other cancer curatively treated and with no evidence of disease for at least 5 years
* Other sever underlying medical conditions, which could impair the ability of the patient to participate in the study
* Previous (within 15 days) or concomitant treatment that modifies intestinal absorption (e.g. metformin, acarbose in diabetic treatment…)
* Probiotics, prebiotics or symbiotics (yogurt or another functional foods) intake in the last 3 weeks
* Use of food supplements or functional foods such as probiotics, prebiotics, symbiotics, vitamins and minerals different than whose established in this study, is not allowed during the study period or previously within 1 week (except for vitamin D, calcium, vitamin B12)
* Total parenteral nutrition within 4 months
* History of allergy to one of the excipients present in the products under evaluation
* Concomitant or within 4 week period administration of any experimental drug, food supplements or nutraceuticals under investigation
* Subjects clearly intending to withdraw from the study if not randomised in a given arm, or subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons
* Subjects with expected non-compliance to protocol guidelines
65 Years
85 Years
ALL
Yes
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Luzia Valentini
Research Scientist
Locations
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Charité - Universitätsmedizin Berlin
Berlin, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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EA1/079/09
Identifier Type: -
Identifier Source: org_study_id