- 2026-01
- Contemporary clinical trials 160
- Simone Baldi
- Francesca Cuffaro
- Edda Russo
- Kate Porter
- William Cheung
- Maria Magdalena Coman
- Marco Garcia Vaquero
- Thomas Lingner
- Maria Cristina Verdenelli
- Gwendolyn Barceló-Coblijn
- Iain Brownlee
- Stefano Fumagalli
- Amedeo Amedei
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 60
- Population
- 120 older adults with confirmed AF and/or HF
- Methods
- Single-center, prospective, parallel-group randomized controlled trial; intervention group consumes one AMBROSIA nutritional bar daily for six months; control group receives individualized dietary counseling
- Blinding
- Open-label
- Duration
- six months
- Funding
- Unclear
Background and aims
Atrial fibrillation (AF), heart failure (HF), and undernutrition represent a complex triad with major clinical and socioeconomic consequences in older adults, often predisposing to frailty. Undernutrition often remains underdiagnosed due to a reliance on weight-based measures and limited awareness of inflammation-related cachexia. The AMBROSIA study aims to fill these gaps by exploring the response of the microbiota-inflammation-brain axis to a targeted, fortified food product-based intervention, with comprehensive outcome assessments, alongside mechanistic/exploratory -omics analyses and gut microbiota (GM) functional profiling.Methods and results
This single-center, prospective, parallel-group randomized controlled trial aims to enroll 120 older adults with confirmed AF and/or HF. Participants will be randomized 1:1 into an intervention group (n = 60) or control group (n = 60). All participants receive individualized dietary counseling; the intervention group additionally consumes one AMBROSIA nutritional bar daily for six months. The bar contains hydrolyzed proteins, inulin, CoQ₁₀, and probiotics (L. rhamnosus IMC 501® and L. paracasei IMC 502®) in a flavonoid-rich chocolate matrix. Clinical, cognitive, and nutritional data, along with blood, saliva, urine, and stool samples, will be collected at baseline, 3, and 6 months. The primary endpoint is the change in skeletal muscle mass, physical function and frailty, while secondary endpoints include changes in nutritional status, inflammation, GM, metabolomics, and quality of life.Conclusion
By integrating cutting-edge omics tools and a multidimensional nutritional strategy, AMBROSIA aims to uncover mechanisms driving undernutrition and identify biomarkers to support personalized interventions for older patients with AF and HF.