Effect of a Combined Exercise and Anti-Inflammatory Nutritional Intervention in Frail Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorFundacion Miguel Servet
About this trial
The goal of this clinical trial is to evaluate whether a combined intervention of therapeutic exercise and anti-inflammatory nutritional supplementation improves physical performance and reduces systemic inflammation in frail, malnourished older adults. The main questions it aims to answer are:
Does the addition of an anti-inflammatory nutritional supplement (Alisenoc™) to a multicomponent exercise program (Vivifrail) lead to greater improvements in physical performance compared to standard exercise and conventional nutritional support?
Does the combined intervention reduce levels of inflammatory biomarkers (e.g., IL-6, TNF-α, IL-8, GDF-15) in this population?
Are there measurable changes in body composition (e.g., muscle mass, fat mass, bone health) following the intervention?
Does the intervention impact clinical outcomes such as hospital readmissions, functional independence, or mortality over the following 12 months?
Researchers will compare two groups:
One group receiving the Vivifrail exercise program plus a daily dose of the anti-inflammatory nutritional supplement Alisenoc™.
Another group receiving the same Vivifrail program plus an isocaloric, protein-equivalent conventional supplement.
Participants will:
Be aged 75 years or older and identified as frail and malnourished according to Fried and GLIM criteria.
Undergo baseline evaluation including functional performance (SPPB), body composition via bioimpedance analysis, and blood sample collection for inflammatory biomarkers.
Be randomly assigned to one of the two intervention groups.
Follow a 12-week home-based multicomponent exercise program guided by educational materials and supervised remotely.
Consume the assigned oral nutritional supplement daily for the same 12-week period.
Return for outcome assessments at 12 weeks, and again at 6 and 12 months for long-term follow-up.
All study procedures will take place at the Hospital Universitario de Navarra (HUN), Spain. Participants will be recruited from outpatient geriatrics and nutrition clinics and assessed at a dedicated research unit with nursing support. The intervention is designed to be feasible, scalable, and representative of real-world multidisciplinary care in older populations with high vulnerability.
The study aims to provide evidence for an integrative, personalized approach to reversing frailty through combined physical and nutritional strategies targeting the biological basis of inflammaging.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged ≥ 75 years.
Diagnosis of frailty according to Linda Fried's criteria.
Diagnosis of malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria.
Barthel Index score ≥ 60 points.
Disqualifiers
Presence of type 1 or type 2 diabetes mellitus with poor metabolic control (HbA1c > 8% or insulin-dependent).
Oropharyngeal dysphagia to liquids that prevents safe intake of oral supplementation.
Moderate-to-severe cognitive impairment, defined as a score ≥ 5 on the Global Deterioration Scale (GDS) of Reisberg.
Refusal to sign the informed consent by the patient, primary caregiver, or legal representative, or inability to obtain it.
Trial design
Design model
Parallel
Treatments tested in this trial
Anti-Inflammatory Supplement
Dietary supplementA daily oral dose of Alisenoc™, an anti-inflammatory nutritional supplement specifically designed for older adults. Alisenoc™ contains olive oil polyphenols, omega-3 fatty acids (EPA/DHA), leucine-enriched protein, and antioxidant micronutrients to target inflammaging, sarcopenia, and nutritional deficiencies. Participants will be followed at 12 weeks, and at 6 and 12 months for functional, biochemical, and clinical outcomes.
Conventional Nutritional Supplement
Dietary supplementthey will receive a conventional oral nutritional supplement that is isocaloric and protein-equivalent to the experimental product, but without anti-inflammatory ingredients. This standard supplement reflects routine nutritional support typically provided in geriatric clinical practice for malnourished patients. It contains energy, protein, and micronutrients but no specific anti-inflammatory components such as olive polyphenols or omega-3 fatty acids.
Treatment groups
158 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Experimental - Combined Exercise + Anti-Inflammatory Supplement (Alisenoc™)Experimental treatment 1 intervention
Group B: Arm 2: Active Comparator - Exercise + Conventional Nutritional SupplementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Short Physical Performance Battery (SPPB)
Change in physical performance assessed by the Short Physical Performance Battery (SPPB), a validated composite measure of lower extremity function. The SPPB includes three components: balance tests, gait speed, and repeated chair stands. Scores range from 0 to 12, with higher scores indicating better physical function and mobility.
Time frame
From baseline to 12 weeks after intervention startSecondary outcomes
1
Phase Angle (PhA)
Change in phase angle (degrees), calculated via vectorial bioimpedance analysis. (BIA 101 BIVA PRO, Akern Bioresearch, Italy).
Time frame
Baseline, 12 weeks2
Skeletal Muscle Mass Index (SMMI)
Change in skeletal muscle mass index (kg/m²), calculated by dividing appendicular muscle mass (kg) by height squared (m²)
Time frame
Baseline, 12 weeks3
Inflammatory Biomarkers
Change in serum IL-6 concentration (pg/mL), IL-8 concentration (pg/mL), TNF-α concentration (pg/mL), and GDF-15 concentration (pg/mL) measured using immunoassay techniques (Olink)
Time frame
Baseline and 12 weeks post-intervention4
Handgrip Strength (Jamar® Dynamometer)
Change in upper body strength measured by maximum handgrip strength (kg) using a calibrated Jamar® dynamometer. Participants will perform three trials with their dominant hand, and the highest value in kilograms will be recorded. Higher values indicate better muscle strength.
Time frame
Baseline, 12 weeks, post-interventionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundacion Miguel Servet
Lead sponsor
Adventia Pharma
Collaborator
Source ClinicalTrials.gov
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