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

NCT ID: NCT07000500

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-20

Study Completion Date

2025-11-20

Brief Summary

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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

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Conditions

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Cognitive Dysfunction, Cognitive Disorder Dietary Supplements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Nutritional Supplement

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maria Paço

OTHER

Sponsor Role lead

Responsible Party

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Maria Paço

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Escola Superior de Saúde do Vale do Ave

Vila Nova de Famalicão, Braga District, Portugal

Site Status

Countries

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Portugal

Other Identifiers

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INSIDE_2025

Identifier Type: -

Identifier Source: org_study_id

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