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| Sponsor: | Charite University, Berlin, Germany |
|---|---|
| Information provided by (Responsible Party): | Luzia Valentini, Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT01179789 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Aged Healthy |
Behavioral: Optimal Diet Dietary Supplement: VSL#3® Dietary Supplement: AISA-5203-L Dietary Supplement: Argan oil |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official 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 |
| Estimated Enrollment: | 48 |
| Study Start Date: | October 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Optimal Diet
Diet advices will receive the Optimal Diet for Elderly
|
Behavioral: Optimal Diet
a dietician will train each subject (or the caregiver) to use the personalized diet on web platform
|
|
Experimental: VSL#3
Diet advices + VSL-3: will receive the Optimal Diet for Elderly + VSL#3® probiotic blend
|
Dietary Supplement: VSL#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
|
|
Experimental: AISA-5203-L
Diet advices + 5203-L: will receive the Optimal Diet for Elderly + AISA-5203-L fruit extracted terpene
|
Dietary Supplement: AISA-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
|
|
Experimental: Argan oil
Diet advices + Argan oil: will receive the Optimal Diet for Elderly + Argan
|
Dietary Supplement: Argan 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
|
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
Eligibility| Ages Eligible for Study: | 65 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Luzia Valentini, Research Scientist, Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT01179789 History of Changes |
| Other Study ID Numbers: | EA1/079/09 |
| Study First Received: | August 5, 2010 |
| Last Updated: | October 27, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Healthy Elderly People |