Clinical trial NCT01069445: Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene
Official title: Open Label, Randomized Study of the Impact of Diet on Gut Microbiota, Inflammageing and Oxidative Stress in Elderly People. Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene. French Part of a Multicentric European Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Elderly People
Keywords: diet
probiotics
inflammaging
oxidative stress
gut microbiota
food complements
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Age: from 65 to 85 years
* 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:

* History of significant neurologic or psychiatric disorders including dementia, seizures, bipolar disorder
* 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
* Chronic anti-inflammatory therapy with FANS or previous therapy within 20 days from the beginning of the study. The occasional use of anti-inflammatory therapy is not an exclusion criteria, but the use is not allowed within 3 days before the analysis and for more than 8 days/2 months during the study
* Previous (within 15 days) or concomitant treatment that modifies intestinal absorption (e.g. metformine, acarbose in diabetic treatment...)
* Probiotics, prebiotics or simbiotics (yogurt or another functional foods) intake in the last 3 weeks
* Use of food supplements or functional foods such as probiotics, prebiotics, simbiotics, 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

Primary outcomes:
measure: The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein)
timeFrame: 2 months
Secondary outcomes:
measure: 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
timeFrame: 2 months
measure: 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
timeFrame: 2 months
measure: Gut microbiota: expression of 16S ribosomal RNA in bacterial groups from faeces. Ratio between lactobacilli and clostridia bacteria. Real time PCR and PCR DGGE
timeFrame: 2 months
measure: Quality of life: SF-36, GHQ, and daily VAS, ECOG performance status, IADL, Speilbeger Anxiety Scale, CES-D scale
timeFrame: 2 months
measure: Physical performance status (SPPB), muscle function (hand-grip dynamometry), and physical activity level (IPAQ)
timeFrame: 2 months
measure: Compliance to the web diet advices and to the nutraceutical supplement intake (daily VAS)
timeFrame: 2 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: Pôle de gerontology Clinique Hôpital Xavier Arnozan , University Hospital, Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Isabelle BOURDEL-MARCHASSON, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.