MedDataX Logo

Nutritional Effects of Supplementing Nonagenarians With a Supplement Based on a Fruit From the Cerrado: Buriti

NCT ID: NCT07289867

Last Updated: 2025-12-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The population aged over 90 is growing worldwide, and the search for strategies to promote a better quality of life for the older persons is a challenge for science. Advancing age is associated with several physiological changes leading to different diseases, among which malnutrition and sarcopenia stand out. Malnutrition prevention and treatment are based on functional food/nutritional interventions, such as oral supplement use. However, studies evaluating the effectiveness of these supplements in nonagenarians are still scarce in the literature. The present study aimed to evaluate the use of a buriti fruit (Mauritia flexuosa) supplement in persons 90 years and older. The study included 40 individuals who were randomized into two groups. The group Supplement Test (ST) used a Buriti-based supplement with full vitamins and minerals; the control group used a capsule containing the same composition of vitamins and minerals as the test supplement, which was called Vitamin Mix (VM). The intervention lasted 12 weeks. The following analyses were carried out before and after this period: Mini Nutritional Assessment (MNA) questionnaire, handgrip strength (HGS), biochemical tests, and anthropometric measurements. The main results showed that the Buriti supplement led to a significant increase in body weight, Body Mass Index (BMI), handgrip strength, and globulins, when compared to the group that used the vitamin mix. Therefore, it can be concluded that the buriti supplement promotes an improvement in body composition, increased strength, and globulins in nonagenarians, and may be a viable and effective strategy for malnutrition treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition in the Elderly

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Nonagenarians malnutrition Cerrado nutritional supplements

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This randomized clinical trial included 40 eligible participants, randomly assigned into two groups of 20. One group received a buriti-based supplement (Supplement Test - ST), while the control group received capsules containing the same vitamins and minerals (Vitamin Mix - VM). The intervention lasted 12 weeks, during which participants were evaluated before and after for nutritional status using the HAND test, anthropometric measurements, handgrip strength (HGS), and biochemical blood tests.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supplement Group

Participants received the supplement test (Nutricer Energia Zero-lactose) daily for 3 months

Group Type EXPERIMENTAL

Nutricer Energia Zero-lactose

Intervention Type DIETARY_SUPPLEMENT

Daily administration of two tablespoons of solubilized in whole milk once a day for 3 months.

Control Group (Multivitamin Mix)

Participants received a multivitamin mix daily for 3 months

Group Type ACTIVE_COMPARATOR

Multivitamin Mix

Intervention Type DIETARY_SUPPLEMENT

Daily administration of one multivitamin capsule for 3 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutricer Energia Zero-lactose

Daily administration of two tablespoons of solubilized in whole milk once a day for 3 months.

Intervention Type DIETARY_SUPPLEMENT

Multivitamin Mix

Daily administration of one multivitamin capsule for 3 months.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Supplement Group Control Group (Multivitamin Mix)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Participants aged 90 or over were selected from the database of the Reference Center for Elderly Health Care in Montes Claros, MG .
Minimum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sergio Henrique Sousa Santos

Professor / principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sérgio H Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of Minas Gerais

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

State University of Minas Gerais

Montes Claros, Minas Gerais, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

6.790.431

Identifier Type: -

Identifier Source: org_study_id