Effect of a Combined Exercise and Anti-Inflammatory Nutritional Intervention in Frail Older Adults

Summary

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.

Conditions

• Frail Elderly Syndrome
• Malnutrition Elderly

Interventions

DIETARY_SUPPLEMENT

Anti-Inflammatory Supplement

A 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.

DIETARY_SUPPLEMENT

Conventional Nutritional Supplement

they 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.

Sponsors & Collaborators

• Adventia Pharma

  collaborator INDUSTRY

• Fundacion Miguel Servet

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2026-10-01

Completion

2027-10-01