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

NCT07182292 | Not Yet Recruiting

• 1 other identifier: AliFrail-HUN-2025
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

inflammaging; malnutrition; frailty

Outcome Measures

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.

  From baseline to 12 weeks after intervention start

Secondary Outcomes (10)

• Phase Angle (PhA)

  Baseline, 12 weeks

• Skeletal Muscle Mass Index (SMMI)

  Baseline, 12 weeks

• Inflammatory Biomarkers

  Baseline and 12 weeks post-intervention

• Handgrip Strength (Jamar® Dynamometer)

  Baseline, 12 weeks, post-intervention

• Barthel Index Score

  Baseline, 12 weeks, and 12 months post-intervention

Study Arms (2)

Arm 1: Experimental - Combined Exercise + Anti-Inflammatory Supplement (Alisenoc™)

EXPERIMENTAL

Participants included in this group will perform physical exercise (Vivifrail) + Anti-Inflammatory Supplement

Dietary Supplement: Anti-Inflammatory Supplement

Arm 2: Active Comparator - Exercise + Conventional Nutritional Supplement

ACTIVE COMPARATOR

Participants included in this group will perform physical exercise (Vivifrail) + Conventional Nutritional Supplement

Dietary Supplement: Conventional Nutritional Supplement

Interventions

Anti-Inflammatory Supplement DIETARY_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.

Arm 1: Experimental - Combined Exercise + Anti-Inflammatory Supplement (Alisenoc™)

Conventional Nutritional Supplement DIETARY_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.

Arm 2: Active Comparator - Exercise + Conventional Nutritional Supplement

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• Absence of advanced chronic kidney disease (defined as glomerular filtration rate \< 25 mL/min/1.73m²).
• Absence of terminal illness as defined by SECPAL (Spanish Society for Palliative Care) criteria.

You may not qualify if:

• 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.
• Known allergy or intolerance to any component of the study supplements.
• Institutionalized in a long-term care or residential facility.

Sponsors & Collaborators

• Fundacion Miguel Servet: lead
• Adventia Pharma: collaborator

MeSH Terms

Conditions

Malnutrition; Frailty

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bernardo Abel Cedeno-Veloz, MD PhD

CONTACT

0034637418620; ba.cedeno.veloz@navarra.es

Nicolás Martínez-Velilla, MD PhD

CONTACT

0034670900434; nicolas.martinez.velilla@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share