Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene (RISTOMED)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01069445
First received: February 15, 2010
Last updated: May 31, 2011
Last verified: May 2011

February 15, 2010
May 31, 2011
March 2010
April 2011   (final data collection date for primary outcome measure)
The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01069445 on ClinicalTrials.gov Archive Site
  • Inflammageing status: WBC, hemoglobin, ERS, fibrinogen, total cholesterol, triglycerides, insulin, glucose, (and HOMA Index), interleukin-6, TNFα, IL-10, TGF1, IGF-1, adiponectin, lectin, Homocysteine, folic acid and vitamin B12, calprotectin [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Oxidative stress: plasma total antioxidant capacity by TEAA (Trolox Equivalent Antioxidant Activity), glutathione level, the superoxide dismutase, the glutathione peroxidase, the glutathione reductase and the catalase activities [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Gut microbiota: expression of 16S ribosomal RNA in bacterial groups from faeces. Ratio between lactobacilli and clostridia bacteria. Real time PCR and PCR DGGE [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Quality of life: SF-36, GHQ, and daily VAS, ECOG performance status, IADL, Speilbeger Anxiety Scale, CES-D scale [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Physical performance status (SPPB), muscle function (hand-grip dynamometry), and physical activity level (IPAQ) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Compliance to the web diet advices and to the nutraceutical supplement intake (daily VAS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene
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

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Healthy Elderly People
  • 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
  • Behavioral: Optimal Diet
    a dietician will train each subject (or the caregiver) to use the personalized diet on web platform.
  • Active Comparator: Diet advices
    will receive the Optimal Diet for Elderly
    Intervention: Behavioral: Optimal Diet
  • Experimental: Diet advices + VSL-3
    will receive the Optimal Diet for Elderly + VSL#3® probiotic blend
    Intervention: Dietary Supplement: VSL#3® probiotic blend
  • Experimental: Diet advices + 5203-L
    will receive the Optimal Diet for Elderly + AISA-5203-L fruit extracted terpene
    Intervention: Dietary Supplement: AISA-5203-L fruit extracted terpene
  • Experimental: Diet advices + Argan oil
    will receive the Optimal Diet for Elderly + Argan oil
    Intervention: Dietary Supplement: Argan oil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
65 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01069445
CHUBX 2009/08
No
Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Isabelle BOURDEL-MARCHASSON, Professor University Hospital, Bordeaux
University Hospital, Bordeaux
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP