NCT01179789

New E-Service for a Dietary Approach to the Elderly

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Accepted

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

Conditions

• Aged
• Healthy

Interventions

Type	Name	Description
BEHAVIORAL	Optimal Diet	a dietician will train each subject (or the caregiver) to use the personalized diet on web platform
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
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
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

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-08-01
• Completion: 2011-06-01
• First posted: 2010-08-11
• Last updated: 2011-10-31

Locations

1 site across 1 country: Germany