Aged, Healthy
Conditions
Keywords
Healthy Elderly People
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
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
Interventions
BEHAVIORALOptimal Diet
a dietician will train each subject (or the caregiver) to use the personalized diet on web platform
DIETARY_SUPPLEMENTVSL#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
DIETARY_SUPPLEMENTAISA-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
DIETARY_SUPPLEMENTArgan 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
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk) | 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative stress | 2 months | Plasma total antioxidant capacity by TEAA (Trolox Equivalent Antioxidant Activity), glutathione , superoxide dismutase, glutathione peroxidase, glutathione reductase, catalase activities |
| Gut micobiota | 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. |
| Inflammageing status as measure of ageing-associated inflammatory processes | 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 |
| Physical performance status | 2 months | Short physical performance battery (SBBP), muscle function (hand-grip dynamometry, and physical activity level (IPAQ). |
| Compliance | 2 months | Daily visual analogue scales as measures of compliance to web diet advices and to the nutraceutical intake. |
| Quality of life (QoL) | 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. |
Countries
Germany
Outcome results
None listed