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
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Aged
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk)
- 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
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
Luzia Valentini
Research Scientist
Charite University, Berlin, Germany
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
High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk)
Time Frame: 2 months
Secondary Outcomes
- Inflammageing status as measure of ageing-associated inflammatory processes(2 months)
- Oxidative stress(2 months)
- Gut micobiota(2 months)
- Quality of life (QoL)(2 months)
- Physical performance status(2 months)
- Compliance(2 months)