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

NCT07000500 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Maria Paço

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-20
Primary Completion
2025-09-20
Completion
2025-11-20

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07000500 on ClinicalTrials.gov