The Inspire Bio-resource Research Platform for Healthy Aging INSPIRE Platform
ConditionBiological Aging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30+
SponsorUniversity Hospital, Toulouse
About this trial
Since aging is a systemic (not organ-specific) phenomenon, the main objective of Inspire Bio-resource Research Platform for Healthy Aging is to build a comprehensive research platform gathering biological, clinical (including imaging) and digital resources that will be explored to identify robust (set of) markers of aging, age-related diseases and IC evolution. The Inspire Platform will gather data and biospecimens from subjects of different ages (from 30 years or over - no upper limit for age) and functional capacity levels (from robust to frail to disabled) over 10 years.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 30 years-old or over;
Both sexes
Affiliated to a social security scheme
Disqualifiers
severe disease compromising life expectancy at 5 years;
Deprived of their liberty by administrative or judicial decision, or under guardianship
Trial population
Recruitment will be stratified per 10-year age groups, oversampling older people in order to be able to investigate major clinical events (eg, declines on IC, onset of age-related diseases)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
The Inspire Bio-resource Research Platform for Healthy Aging
Other interventionSeveral follow-up visits will be undertaken during the 10-year time frame of this project. Some of these visits are not regularly scheduled and will be conditioned by the remote monitoring of intrinsic capacity (IC) and the onset of other major clinical conditions. Other visits correspond to the regularly scheduled (yearly or every two years (biannual visits), depending on the outcome measures) waves of data collection.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Data collection of key variables and biospecimens
The main outcome of Inspire Bio-resource Research Platform for Healthy Aging is to build a comprehensive research platform gathering biological, clinical (including imaging) and digital resources that will be explored to identify robust (set of) markers of aging, age-related diseases and intrinsic capacities (cognition, mobility, nutrition, hearing and visual capacities, psychological capacity) evolution. The Inspire Platform will gather data and biospecimens from subjects of different ages (from 30 years or over - no upper limit for age) and functional capacity levels (from robust to frail to disabled) over 10 years.
Time frame
through study completion, an average of 10 yearsSecondary outcomes
1
Identification of (a set of) biomarkers of aging through the constitution of a comprehensive biobank comprising: blood, saliva, urine, nasopharyngeal swabbing, skin biopsies and surface samples, dental plaque, faeces, hair bulb.
1\. Markers of aging: The identification of (a set of) markers of aging will be allowed from the constitution of a large dataset of clinical, para-clinical and digital data as well as a comprehensive biobank comprising: blood, saliva, urine, nasopharyngeal swabbing, skin material (swabbing, stripping, biopsies), dental plaque, feces, hair bulb. In this part of the study, we will take advantage of three complimentary approaches to look for the best markers of aging: without a priori approach (omics: transcriptomics, proteomics, lipidomics); semi a priori approach (field-specific omic. I.e. metabolism, inflammation, cell cycle, mitochondrial network…); and targeted approach (pre-identified targets).
Time frame
through study completion, an average of 10 years2
measure intrinsic capacity domains with questionnaire in ICOPE App (developed in collaboration with W.H.O.)
Icope app (developed in collaboration with W.H.O.) for smartphone and tablet to measure intrinsic capacity domains. This app will be used for the remote (at-distance) evaluation and monitoring (self-monitoring, monitoring by a caregiver, or a healthcare provider) of intrinsic capacity domains; for the monitoring, we will use only the Icope Step 1. When declines are detected in the Icope Step 1, we will use the Icope Step 2 (data collected by research nurses in a home visit or at the research facility) to confirm the decline and, then, look for the causes determining such declines.
Time frame
through study completion, an average of 10 years3
Basic and instrumental activities of daily living.
Basic and instrumental activities of daily living (ADL). Basic ADLs will be assessed using the 6-item (eg, bathing, feeding, dressing) Katz scale; instrumental ADLs (IADL) will be assessed using the 8-item (eg, cooking, manipulating money) Lawton scale. These variables are measured as a clinical measurement of functional ability and, thus, healthy aging in late ages, according to WHO definition.
Time frame
through study completion, an average of 10 years4
Mini-nutritional assessment and food frequency questionnaire.
Mini-nutritional assessment (MNA) and food frequency questionnaire. Nutritional status will be evaluated using the MNA (see Vitality description in Icope Step 2). A short (12-item; the question on physical activity has been removed since already investigated using other assessment tools in this project) food frequency questionnaire will be used to assess dietary quality. Nutritional status and diet may affect both intrinsic capacity domains and potential biomarkers of aging.
Time frame
through study completion, an average of 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Toulouse
Lead sponsor
European Regional Development Fund
Collaborator
Source ClinicalTrials.gov