NCT07000500

INSIDE: Intervention in Nutritional Supplementation to Improve Cognitive Decline in Elderly.

INSIDE: Intervenção da Suplementação Nutricional na Melhoria do Declínio Cognitivo no Idoso.

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Maria Paço · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the effect of nutritional supplementation on cognitive performance in older adults over a 90-day period using a double-blind randomized controlled design. The study includes 50 participants, aged 65 or older, randomly assigned to either a supplement group or a placebo group. Participants will be randomly assigned to either the experimental or control group. Assessments will be conducted pre- and post-intervention to determine the effect of the supplementation on cognitive performance. Key outcomes include cognitive status measured by MoCA, adherence to supplementation, and potential side effects. The findings will provide insights into the potential role of nutritional interventions in mitigating age-related cognitive decline.

Conditions

• Cognitive Dysfunction, Cognitive Disorder
• Dietary Supplements

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional Supplement	Participants in this arm will receive a daily dose of a nutritional supplement for 90 consecutive days. The supplement is administered orally and aims to improve cognitive performance in older adults with signs of cognitive decline. Participants will also complete cognitive assessments before and after the intervention.
OTHER	Placebo	Participants in this arm will receive a daily dose of an inert placebo that matches the supplement in appearance, taken orally for 90 consecutive days. The placebo is used as a control to compare the effects of the nutritional supplement on cognitive performance. Participants will undergo the same cognitive assessments as the experimental group.

Timeline

• Start date: 2025-04-20
• Primary completion: 2025-09-20
• Completion: 2025-11-20
• First posted: 2025-06-03
• Last updated: 2025-06-03

Locations

1 site across 1 country: Portugal