Healthy Elderly PeopleRISTOMEDNCT01069445
Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene
A study testing VSL#3® probiotic blend, AISA-5203-L fruit extracted terpene and Argan oil in people with Healthy Elderly People, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly People
- What is being tested?
- VSL#3® probiotic blend, AISA-5203-L fruit extracted terpene and Argan oil
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Pôle de gerontology Clinique Hôpital Xavier Arnozan , University Hospital, Bordeaux
Pessac, 33600
About this study
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. 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.
Read the 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
- Healthy Elderly People
- Being tested
- VSL#3® probiotic blend, AISA-5203-L fruit extracted terpene, Argan oil, Optimal Diet
- Keywords
- diet, probiotics, inflammaging, oxidative stress, gut microbiota, food complements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3® probiotic blendDietary supplement
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 supplement
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 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
Optimal DietBehavioural
a dietician will train each subject (or the caregiver) to use the personalized diet on web platform.
| Study group | Role | What they receive |
|---|---|---|
| Diet advices | Active comparator | will receive the Optimal Diet for Elderly Receives: Behavioral: Optimal Diet |
| Diet advices + VSL-3 | Experimental | will receive the Optimal Diet for Elderly + VSL#3® probiotic blend Receives: Dietary Supplement: VSL#3® probiotic blend |
| Diet advices + 5203-L | Experimental | will receive the Optimal Diet for Elderly + AISA-5203-L fruit extracted terpene Receives: Dietary Supplement: AISA-5203-L fruit extracted terpene |
| Diet advices + Argan oil | Experimental | will receive the Optimal Diet for Elderly + Argan oil Receives: Dietary Supplement: Argan oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein)
Measured: 2 months
Secondary outcomes (6)
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
Measured: 2 months
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
Measured: 2 months
Gut microbiota: expression of 16S ribosomal RNA in bacterial groups from faeces. Ratio between lactobacilli and clostridia bacteria. Real time PCR and PCR DGGE
Measured: 2 months
Quality of life: SF-36, GHQ, and daily VAS, ECOG performance status, IADL, Speilbeger Anxiety Scale, CES-D scale
Measured: 2 months
Physical performance status (SPPB), muscle function (hand-grip dynamometry), and physical activity level (IPAQ)
Measured: 2 months
Compliance to the web diet advices and to the nutraceutical supplement intake (daily VAS)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy Elderly PeopleStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Investigators
- Isabelle BOURDEL-MARCHASSON, Professor, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069445
- Sponsor's protocol ID
- CHUBX 2009/08
- Acronym
- RISTOMED
- Status last verified
- May 2011
- First submitted
- 15 Feb 2010
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11053678Wener 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.
PubMed 11036829Mendall 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.
PubMed 8616412Devaraj 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.
PubMed 15899961Ostan 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.
PubMed 26249791Valentini 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.
PubMed 25453395
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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. French Part of a Multicentric European Study
- ClinicalTrials.gov ID
- NCT01069445
- Acronym / sponsor ID
- RISTOMED / CHUBX 2009/08
- Conditions
- Healthy Elderly People
- Keywords
- diet, probiotics, inflammaging, oxidative stress, gut microbiota, food complements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diet advices | Active comparator | Behavioral: Optimal Dietwill receive the Optimal Diet for Elderly |
| Diet advices + VSL-3 | Experimental | Dietary Supplement: VSL#3® probiotic blendwill receive the Optimal Diet for Elderly + VSL#3® probiotic blend |
| Diet advices + 5203-L | Experimental | Dietary Supplement: AISA-5203-L fruit extracted terpenewill receive the Optimal Diet for Elderly + AISA-5203-L fruit extracted terpene |
| Diet advices + Argan oil | Experimental | Dietary Supplement: Argan oilwill receive the Optimal Diet for Elderly + Argan oil |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSL#3® probiotic blendProduct 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 | Diet advices + VSL-3 |
| AISA-5203-L fruit extracted terpeneProduct 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 | Diet advices + 5203-L |
| Argan oilProduct should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water | Dietary supplement | Diet advices + Argan oil |
| Optimal Dieta dietician will train each subject (or the caregiver) to use the personalized diet on web platform. | Behavioural | Diet advices |
Primary outcome
The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein)
Time frame: 2 months
6 secondary outcomes
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
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
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
Quality of life: SF-36, GHQ, and daily VAS, ECOG performance status, IADL, Speilbeger Anxiety Scale, CES-D scale
Time frame: 2 months
Physical performance status (SPPB), muscle function (hand-grip dynamometry), and physical activity level (IPAQ)
Time frame: 2 months
Compliance to the web diet advices and to the nutraceutical supplement intake (daily VAS)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
- Background: PubMed 11053678Franceschi 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.
- Background: PubMed 11036829Wener 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.
- Background: PubMed 8616412Mendall 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.
- Background: PubMed 15899961Devaraj 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.
- Derived from this study: PubMed 26249791Ostan 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.
- Derived from this study: PubMed 25453395Valentini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle BOURDEL-MARCHASSON, Professor principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSL#3® probiotic blend, AISA-5203-L fruit extracted terpene and Argan oil in people with Healthy Elderly People, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01069445, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.