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
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk)
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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 exclusion criteria, but the use is not allowed within 3 days before the analysis and for more than 8 days/2 months during the study
- •Previous (within 15 days) or concomitant treatment that modifies intestinal absorption (e.g. metformin, acarbose in diabetic treatment...)
- •Probiotics, prebiotics or symbiotics (yogurt or another functional foods) intake in the last 3 weeks
- •Use of food supplements or functional foods such as probiotics, prebiotics, symbiotics, vitamins and minerals different than whose established in this study, is not allowed during the study period or previously within 1 week (except for vitamin D, calcium, vitamin B12)
- •Total parenteral nutrition within 4 months
- •History of allergy to one of the excipients present in the products under evaluation
- •Concomitant or within 4 week period administration of any experimental drug, food supplements or nutraceuticals under investigation
- •Subjects clearly intending to withdraw from the study if not randomised in a given arm, or subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons
- •Subjects with expected non-compliance to protocol guidelines
结局指标
主要结局
High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk)
时间窗: 2 months
次要结局
- 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)
研究者
Luzia Valentini
Research Scientist
Charite University, Berlin, Germany