An interventional study of VSL#3® probiotic blend and AISA-5203-L fruit extracted terpene in Healthy Elderly People, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-01.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Prevention
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
University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.
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Exclusion Criteria:
will receive the Optimal Diet for Elderly
Behavioral: Optimal Diet
will receive the Optimal Diet for Elderly + VSL#3® probiotic blend
Dietary Supplement: VSL#3® probiotic blend
will receive the Optimal Diet for Elderly + AISA-5203-L fruit extracted terpene
Dietary Supplement: AISA-5203-L fruit extracted terpene
will receive the Optimal Diet for Elderly + Argan oil
Dietary Supplement: Argan oil
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
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
Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water
a dietician will train each subject (or the caregiver) to use the personalized diet on web platform.
The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein)
Time frame: 2 months
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
Time frame: 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
Time frame: 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
Time frame: 2 months
Quality of life: SF-36, GHQ, and daily VAS, ECOG performance status, IADL, Speilbeger Anxiety Scale, CES-D scale
Time frame: 2 months
Physical performance status (SPPB), muscle function (hand-grip dynamometry), and physical activity level (IPAQ)
Time frame: 2 months
Compliance to the web diet advices and to the nutraceutical supplement intake (daily VAS)
Time frame: 2 months
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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