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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Elderly People
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein)
Time Frame: 2 months
Secondary Outcomes
- 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(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)