- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289867
Nutritional Effects of Supplementing Nonagenarians With a Supplement Based on a Fruit From the Cerrado: Buriti
December 4, 2025 updated by: Sergio Henrique Sousa Santos, Federal University of Minas Gerais
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
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Montes Claros, Minas Gerais, Brazil
- State University of Minas Gerais
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Participants aged 90 or over were selected from the database of the Reference Center for Elderly Health Care in Montes Claros, MG .
Exclusion Criteria:
- Exclusion criteria included severe obesity, decompensated chronic diseases, or inability/refusal to consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supplement Group
Participants received the supplement test (Nutricer Energia Zero-lactose) daily for 3 months
|
Daily administration of two tablespoons of solubilized in whole milk once a day for 3 months.
Other Names:
|
|
Active Comparator: Control Group (Multivitamin Mix)
Participants received a multivitamin mix daily for 3 months
|
Daily administration of one multivitamin capsule for 3 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: Baseline and after 12 weeks of supplementation
|
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
Time Frame: Baseline and after 12 weeks of supplementation.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: Baseline and after 12 weeks of supplementation
|
Body weight (kg) was measured using a calibrated digital scale to assess changes in body mass after supplementation.
|
Baseline and after 12 weeks of supplementation
|
|
Change in Body Mass Index
Time Frame: Baseline and after 12 weeks of supplementation.
|
BMI (kg/m²) was calculated as weight divided by height squared to evaluate body composition changes.
|
Baseline and after 12 weeks of supplementation.
|
|
Change in Serum Globulin Levels
Time Frame: Baseline and after 12 weeks of supplementation.
|
Serum globulin concentration (g/dL) was determined using standard biochemical methods to assess protein metabolism changes.
|
Baseline and after 12 weeks of supplementation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sérgio H Santos, PhD, State University of Minas Gerais
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2024
Primary Completion (Actual)
August 26, 2024
Study Completion (Actual)
November 30, 2024
Study Registration Dates
First Submitted
December 4, 2025
First Submitted That Met QC Criteria
December 4, 2025
First Posted (Actual)
December 17, 2025
Study Record Updates
Last Update Posted (Actual)
December 17, 2025
Last Update Submitted That Met QC Criteria
December 4, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6.790.431
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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