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Enrolling by Invitation

NCT Number: NCT07000500

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

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.

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Key information

Conditions

Cognitive Dysfunction, Cognitive Disorder Cognition Disorders Cognitive Dysfunction Dietary Supplements Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escola Superior de Saúde do Vale do Ave

Vila Nova de Famalicão, Braga District, 4760-409, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional Supplement

Dietary 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.

Placebo

Other

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.

Primary outcomes

  1. Cognitive Performance

    Time frame: baseline and 90 days

    Change in cognitive performance measured by MoCA before and after intervention (90 days)

Secondary outcomes

  1. Adherence to supplementation protocol

    Time frame: 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.

  2. Occurrence of adverse effects

    Time frame: 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.

  3. Self-reported use of other supplements

    Time frame: 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.

  4. Self-perceived quality of life

    Time frame: 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.

  5. Depressive symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maria Paço

Other

Registry information

Official study title

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

Acronym: INSIDE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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