Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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
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


Options:
A: 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 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
B: Inclusion Criteria:

* Patients diagnosed as having cirrhosis of liver at the Inpatient/Outpatient Liver Clinic of Department of Hepatology, PGIMER, Chandigarh, will be candidates for enrollment.
* The diagnosis of cirrhosis of liver will be based on clinical, biochemical, and ultrasonographical or liver histological data.

Exclusion Criteria:

* Alcohol intake during the past 6 weeks
* Hepatocellular carcinoma
* Previous transjugular intrahepatic portosystemic shunt or shunt surgery
* Significant comorbid illness such as heart, respiratory, or renal failure
* Any neurologic diseases such as Alzheimer's disease, Parkinson's disease, and nonhepatic metabolic encephalopathies.
* Patients on psychoactive drugs, such as antidepressants or sedatives
* Those who restart alcohol consumption during follow-up will also be excluded.
C: Inclusion Criteria:

* Age 18 to 70 years
* Fatty liver identified by imaging studies including ultrasound, computer tomography or magnetic resonance imaging
* Elevated alanine aminotransferase (ALT) according to Prati's criteria (\>30 IU/l in men and \>19 IU/l in women)18
* Written informed consent obtained

Exclusion Criteria:

* Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160
* Alcohol consumption above 30 g per week in men or 20 g per week in women
* ALT above 10 times the upper limit of normal
* Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices
* Use of systemic corticosteroids and methotrexate in the last 6 months
* Evidence of hepatocellular carcinoma
* Terminal illness or cancer, unless in complete remission for more than 5 years
D: 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 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. metformine, acarbose in diabetic treatment...)
* Probiotics, prebiotics or simbiotics (yogurt or another functional foods) intake in the last 3 weeks
* Use of food supplements or functional foods such as probiotics, prebiotics, simbiotics, 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

Answer: A