New E-Service for a Dietary Approach to the Elderly

NCT01179789 | Completed Early Phase 1

• 1 other identifier: EA1/079/09
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Aged; Healthy

Keywords

Healthy Elderly People

Outcome Measures

Primary Outcomes (1)

• High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk)

  2 months

Secondary Outcomes (6)

• Inflammageing status as measure of ageing-associated inflammatory processes

  2 months

• Oxidative stress

  2 months

• Gut micobiota

  2 months

• Quality of life (QoL)

  2 months

• Physical performance status

  2 months

Study Arms (4)

Optimal Diet

ACTIVE COMPARATOR

Diet advices will receive the Optimal Diet for Elderly

Behavioral: Optimal Diet

VSL#3

EXPERIMENTAL

Diet advices + VSL-3: will receive the Optimal Diet for Elderly + VSL#3® probiotic blend

Dietary Supplement: VSL#3®

AISA-5203-L

EXPERIMENTAL

Diet advices + 5203-L: will receive the Optimal Diet for Elderly + AISA-5203-L fruit extracted terpene

Dietary Supplement: AISA-5203-L

Argan oil

EXPERIMENTAL

Diet advices + Argan oil: will receive the Optimal Diet for Elderly + Argan

Dietary Supplement: Argan oil

Interventions

Optimal Diet BEHAVIORAL

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

Optimal Diet

VSL#3® DIETARY_SUPPLEMENT

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

VSL#3

AISA-5203-L DIETARY_SUPPLEMENT

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

AISA-5203-L

Argan oil DIETARY_SUPPLEMENT

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

Argan oil

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (6)

• Franceschi C, Valensin S, Bonafe M, Paolisso G, Yashin AI, Monti D, De Benedictis G. The network and the remodeling theories of aging: historical background and new perspectives. Exp Gerontol. 2000 Sep;35(6-7):879-96. doi: 10.1016/s0531-5565(00)00172-8.

  PMID: 11053678 BACKGROUND

• Wener MH, Daum PR, McQuillan GM. The influence of age, sex, and race on the upper reference limit of serum C-reactive protein concentration. J Rheumatol. 2000 Oct;27(10):2351-9.

  PMID: 11036829 BACKGROUND

• Mendall MA, Patel P, Ballam L, Strachan D, Northfield TC. C reactive protein and its relation to cardiovascular risk factors: a population based cross sectional study. BMJ. 1996 Apr 27;312(7038):1061-5. doi: 10.1136/bmj.312.7038.1061.

  PMID: 8616412 BACKGROUND

• Devaraj S, O'Keefe G, Jialal I. Defining the proinflammatory phenotype using high sensitive C-reactive protein levels as the biomarker. J Clin Endocrinol Metab. 2005 Aug;90(8):4549-54. doi: 10.1210/jc.2005-0069. Epub 2005 May 17.

  PMID: 15899961 BACKGROUND

• Ostan R, Bene MC, Spazzafumo L, Pinto A, Donini LM, Pryen F, Charrouf Z, Valentini L, Lochs H, Bourdel-Marchasson I, Blanc-Bisson C, Buccolini F, Brigidi P, Franceschi C, d'Alessio PA. Impact of diet and nutraceutical supplementation on inflammation in elderly people. Results from the RISTOMED study, an open-label randomized control trial. Clin Nutr. 2016 Aug;35(4):812-8. doi: 10.1016/j.clnu.2015.06.010. Epub 2015 Jul 15.

  PMID: 26249791 DERIVED

• Valentini L, Pinto A, Bourdel-Marchasson I, Ostan R, Brigidi P, Turroni S, Hrelia S, Hrelia P, Bereswill S, Fischer A, Leoncini E, Malaguti M, Blanc-Bisson C, Durrieu J, Spazzafumo L, Buccolini F, Pryen F, Donini LM, Franceschi C, Lochs H. Impact of personalized diet and probiotic supplementation on inflammation, nutritional parameters and intestinal microbiota - The "RISTOMED project": Randomized controlled trial in healthy older people. Clin Nutr. 2015 Aug;34(4):593-602. doi: 10.1016/j.clnu.2014.09.023. Epub 2014 Oct 8.

  PMID: 25453395 DERIVED

MeSH Terms

Interventions

argan oil

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 11, 2010
• Study Start: October 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: June 1, 2011
• Last Updated: October 31, 2011

Record last verified: 2011-10

Locations

DE (1)