Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
NCT Number: NCT01179789
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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Notify MeAgeing 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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a dietician will train each subject (or the caregiver) to use the personalized diet on web platform
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
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
Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water
Time frame: 2 months
Time frame: 2 months
WBC, hemoglobin, erythrocyte sedimentation rate, fibrinogen, total cholesterol, triglycerides, insulin, glucose, IL-6, TNFα, IL-10, TGF-1, IGF-1, adiponectin, leptin, homocysteine, folic acid and vitamin B12
Time frame: 2 months
Plasma total antioxidant capacity by TEAA (Trolox Equivalent Antioxidant Activity), glutathione , superoxide dismutase, glutathione peroxidase, glutathione reductase, catalase activities
Time frame: 2 months
Expression of 16S ribosomal RNA bacterial groups from feces by RT-PCR. Ratio between lactobacilli and clostridia bacteria as measure of impact of personalized nutrition with and without nutraceuticals on gut microbiota.
Time frame: 2 months
Daily visual analogue scale, SF-36 and General Health Questionnaire (GHQ) as direct measures of QoL. ECOG performance status, IADL, Spielberger Anxiety Index (SAI), and CED-D scale as indirect measures of quality of life.
Time frame: 2 months
Short physical performance battery (SBBP), muscle function (hand-grip dynamometry, and physical activity level (IPAQ).
Time frame: 2 months
Daily visual analogue scales as measures of compliance to web diet advices and to the nutraceutical intake.
Charite University, Berlin, Germany
Other
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. German Part of a Multicentric European Study
Acronym: RISTOMED
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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