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

Not Applicable

• Conditions: Cognitive Dysfunction, Cognitive Disorder; Dietary Supplements

• Registration Number: NCT07000500
• Lead Sponsor: Maria Paço

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-20
• Status Verified: 2025-05
• Study First Submitted: 2025-05-24
• Study First Submitted QC: 2025-05-24
• Last Update Submitted: 2025-05-24
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03
• Primary Completion: 2025-09-20
• Study Completion: 2025-11-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Inclusion Criteria:

Community-dwelling adults aged 65 years or older Evidence of mild cognitive decline (score < 26 on the Montreal Cognitive Assessment - MoCA) Ability to provide written informed consent Willingness and ability to comply with study procedures and attend scheduled evaluations

Exclusion Criteria

Diagnosis of dementia or any neurodegenerative disease (e.g., Alzheimer's, Parkinson's) Epilepsy and neurologically related conditions Severe sensory deficits (e.g., profound visual or hearing impairment) that impair cognitive assessment Current use of cognitive-enhancing medications or supplements that cannot be discontinued History of allergy or intolerance to components of the nutritional supplement Unstable chronic medical conditions (e.g., uncontrolled diabetes, heart failure, renal insufficiency) Participation in another clinical trial in the previous 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive Performance	baseline and 90 days	Change in cognitive performance measured by MoCA before and after intervention (90 days)

Secondary Outcome Measures

Name	Time	Method
Adherence to supplementation protocol	Daily, from Day 1 to Day 90	Adherence will be monitored through a participant-completed intake diary, in which each participant records daily supplement or placebo consumption over the 90-day period. Adherence will be calculated as the percentage of days with confirmed intake out of the total study period. High adherence is defined as ≥80% of doses taken.
Occurrence of adverse effects	Continuous, from baseline to Day 90	Participants will be asked to report any physical or psychological symptoms that arise during the 90-day supplementation period. Data will be collected through structured interviews at the end of the study and verified against notes recorded in the daily intake diary. Symptoms will be classified according to severity (mild, moderate, severe) and suspected relation to the intervention.
Self-reported use of other supplements	Baseline and 90 days	At baseline and at the end of the study, participants will complete a questionnaire about their regular use of other dietary supplements or medications. This information will help identify potential confounding factors related to cognitive performance.
Self-perceived quality of life	baseline and 90 days	Quality of life will be assessed using a brief, validated self-report questionnaire (e.g., EQ-5D or WHOQOL), administered before and after the intervention. The tool measures domains such as physical health, mental well-being, and social functioning. Scores will be compared to evaluate potential changes associated with the intervention.
Depressive symptoms	Baseline and Day 90	Symptoms of depression will be assessed using a short validated screening tool (e.g., Geriatric Depression Scale - short form) at baseline and post-intervention. The tool provides a numerical score that will be used to evaluate changes in depressive symptomatology throughout the study period.

Trial Locations

Locations (1)

Escola Superior de Saúde do Vale do Ave; 🇵🇹 Vila Nova de Famalicão, Braga, Portugal