CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 target
Drug / intervention
VSL#3® probiotic blend +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01069445
NCT01069445N/ACompleted

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. French Part of a Multicentric European Study

University Hospital, Bordeaux·interventional·Posted Feb 17, 2010·Updated Jun 1, 2011

In Brief

A clinical study evaluating VSL#3® probiotic blend, AISA-5203-L fruit extracted terpene, and 2 other interventions for Healthy Elderly People. Completed, enrolled 48 participants across 1 site.

Detailed 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 This study will focus on the development of a specific dietary approach through an E-Health dietary service, associated or not to nutraceutical food supplements intake, to modulate the oxidative stress, inflammageing and gut microflora in the elderly people.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2010
Enrollment StartMar 1, 2010
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.4 years ago

Interventions

VSL#3® probiotic blenddietary

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

AISA-5203-L fruit extracted terpenedietary

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

Argan oildietary

Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water

Optimal Dietbehavioral

a dietician will train each subject (or the caregiver) to use the personalized diet on web platform.