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Enrolling by invitation NCT07000500

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

No phase Interventional Cognitive Dysfunction, Cognitive Disorder Dietary Supplements

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nutritional Supplement, Placebo.
Who it may be relevant to
Registry conditions: Cognitive Dysfunction, Cognitive Disorder, Dietary Supplements. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Cognitive Performance [Time frame: baseline and 90 days]
Secondary outcome measures (5)
  • Adherence to supplementation protocol [Time frame: Daily, from Day 1 to Day 90]
  • Occurrence of adverse effects [Time frame: Continuous, from baseline to Day 90]
  • Self-reported use of other supplements [Time frame: Baseline and 90 days]
  • Self-perceived quality of life [Time frame: baseline and 90 days]
  • Depressive symptoms [Time frame: Baseline and Day 90]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Portugal · 1 center
  • Escola Superior de Saúde do Vale do Ave — Vila Nova de Famalicão

Identifiers

NCT: NCT07000500 · INSIDE_2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗