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

NCT07000500 | Enrolling By Invitation

• 1 other identifier: INSIDE_2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction, Cognitive Disorder; Dietary Supplements

Keywords

Cognitive Decline; Mild Cognitive Impairment; Aging; Nutritional Supplementation

Outcome Measures

Primary Outcomes (1)

• Cognitive Performance

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

  baseline and 90 days

Secondary Outcomes (5)

• Adherence to supplementation protocol

  Daily, from Day 1 to Day 90

• Occurrence of adverse effects

  Continuous, from baseline to Day 90

• Self-reported use of other supplements

  Baseline and 90 days

• Self-perceived quality of life

  baseline and 90 days

• Depressive symptoms

  Baseline and Day 90

Study Arms (2)

Nutritional Supplement

EXPERIMENTAL

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.

Dietary Supplement: Nutritional Supplement

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

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.

Nutritional Supplement

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.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Maria Paço: lead

Study Sites (1)

Escola Superior de Saúde do Vale do Ave

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

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 3, 2025
• Study Start: April 20, 2025
• Primary Completion: September 20, 2025
• Study Completion: November 20, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

PT (1)