NCT07289867

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 4, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

NonagenariansmalnutritionCerradonutritional supplements

Outcome Measures

Primary Outcomes (2)

  • Change in Body Weight

    Body weight (kg) was measured using a calibrated digital scale to evaluate changes after supplementation.

    Baseline and after 12 weeks of supplementation

  • Change in Muscle Strength

    Muscle strength was assessed using a handgrip dynamometer to evaluate functional improvement following 12 weeks of supplementation.

    Baseline and after 12 weeks of supplementation.

Secondary Outcomes (3)

  • Change in Body Weight

    Baseline and after 12 weeks of supplementation

  • Change in Body Mass Index

    Baseline and after 12 weeks of supplementation.

  • Change in Serum Globulin Levels

    Baseline and after 12 weeks of supplementation.

Study Arms (2)

Supplement Group

EXPERIMENTAL

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

Dietary Supplement: Nutricer Energia Zero-lactose

Control Group (Multivitamin Mix)

ACTIVE COMPARATOR

Participants received a multivitamin mix daily for 3 months

Dietary Supplement: Multivitamin Mix

Interventions

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

Also known as: Supplement Group
Supplement Group
Multivitamin MixDIETARY_SUPPLEMENT

Daily administration of one multivitamin capsule for 3 months.

Also known as: Control Group (Multivitamin Mix)
Control Group (Multivitamin Mix)

Eligibility Criteria

Age90 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of Minas Gerais

Montes Claros, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sérgio H Santos, PhD

    State University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor / principal investigator

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

May 1, 2024

Primary Completion

August 26, 2024

Study Completion

November 30, 2024

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations