Effect of a PROtein-enriched MEDiterranean diet and EXercise (PROMED-EX) on nutritional status and cognitive performance in older adults at risk of undernutrition and cognitive decline: the PROMED-EX randomized controlled trial.

Both dietary intervention groups showed significant improvements in nutritional status compared to controls after 6 months.

• Mean difference in MNA score was 2.7 (95% CI: 1.3, 4.2) for PROMED and 2.9 (95% CI: 1.5, 4.3) for PROMED-EX compared with CON (both P < 0.001)
• Baseline mean MNA score was 22.5 ± 2.3, indicating participants were at risk of undernutrition
• MNA scale ranges from 0-30 points
• 105 community-dwelling older adults were randomized; 69% female, mean age 67.7 ± 6.1 years

Cognitive function improved significantly in both intervention groups compared to the control group.

• Neurocognitive test battery (NTB) z-score differences were 0.3 (95% CI: 0.1, 0.5; P = 0.01) for PROMED and 0.2 (95% CI: 0.0, 0.4; P = 0.02) for PROMED-EX compared with CON
• Cognitive outcomes were measured using a neurocognitive test battery (NTB) z-score as a secondary outcome
• Both intervention groups showed statistically significant improvements despite the modest effect sizes

Diet quality scores increased significantly in both intervention groups relative to controls.

• Mean differences in PROMED diet quality score (0-14 scale) were 4.0 (95% CI: 2.9, 5.0) for PROMED and 3.9 (95% CI: 2.8, 4.9) for PROMED-EX compared with CON (both P < 0.001)
• Dietary intervention consisted of personalized dietary counseling aimed at a protein-enriched Mediterranean diet
• Control group received only a healthy eating leaflet

Adding home-based exercise to dietary counseling (PROMED-EX) provided additional benefits for physical performance and quality of life despite low exercise adherence.

• Additional benefits were observed for physical performance and health-related quality of life in the PROMED-EX group
• Adherence to the exercise component was described as low
• No statistically significant additional benefit of exercise over diet alone was observed for the primary outcome of nutritional status

The trial enrolled older adults at risk of both undernutrition and cognitive decline, randomized to three groups using personalized counseling versus a control leaflet.

• 105 participants were randomized to one of three groups: PROMED-EX (dietary counseling plus home-based exercise), PROMED (dietary counseling only), or CON (healthy eating leaflet)
• Participants were community-dwelling older adults; 69% female, aged 67.7 ± 6.1 years
• Intervention duration was 6 months
• Analyses followed an intention-to-treat approach using linear regression
• Registered at clinicaltrials.gov as NCT05166564