Malnutrition in the ElderlyNCT07289867
Nutritional Effects of Supplementing Nonagenarians With a Supplement Based on a Fruit From the Cerrado: Buriti
A study testing Nutricer Energia Zero-lactose and Multivitamin Mix in people with Malnutrition in the Elderly, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 90 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition in the Elderly
- What is being tested?
- Nutricer Energia Zero-lactose and Multivitamin Mix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 90 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants aged 90 or over were selected from the database of the Reference Center for Elderly Health Care in Montes Claros, MG .
Who cannot join
- Exclusion criteria included severe obesity, decompensated chronic diseases, or inability/refusal to consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Malnutrition in the Elderly
- Being tested
- Nutricer Energia Zero-lactose, Multivitamin Mix
- Keywords
- Nonagenarians, malnutrition, Cerrado, nutritional supplements
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutricer Energia Zero-lactoseDietary supplement
Also called Supplement Group
Daily administration of two tablespoons of solubilized in whole milk once a day for 3 months.
Multivitamin MixDietary supplement
Also called Control Group (Multivitamin Mix)
Daily administration of one multivitamin capsule for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Supplement Group | Experimental | Participants received the supplement test (Nutricer Energia Zero-lactose) daily for 3 months Receives: Dietary Supplement: Nutricer Energia Zero-lactose |
| Control Group (Multivitamin Mix) | Active comparator | Participants received a multivitamin mix daily for 3 months Receives: Dietary Supplement: Multivitamin Mix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Body weight (kg) was measured using a calibrated digital scale to evaluate changes after supplementation.
Measured: 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.
Measured: Baseline and after 12 weeks of supplementation.
Secondary outcomes (3)
Change in Body Weight
Body weight (kg) was measured using a calibrated digital scale to assess changes in body mass after supplementation.
Measured: Baseline and after 12 weeks of supplementation
Change in Body Mass Index
BMI (kg/m²) was calculated as weight divided by height squared to evaluate body composition changes.
Measured: Baseline and after 12 weeks of supplementation.
Change in Serum Globulin Levels
Serum globulin concentration (g/dL) was determined using standard biochemical methods to assess protein metabolism changes.
Measured: Baseline and after 12 weeks of supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 May 2024
- Primary completion26 Aug 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition in the ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Henrique Sousa Santos, Federal University of Minas Gerais
- Investigators
- Sérgio H Santos, PhD, Principal investigator, State University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289867
- Sponsor's protocol ID
- 6.790.431
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Effects of Supplementing Nonagenarians With a Supplement Based on a Fruit From the Cerrado: Buriti
- ClinicalTrials.gov ID
- NCT07289867
- Acronym / sponsor ID
- 6.790.431
- Conditions
- Malnutrition in the Elderly
- Keywords
- Nonagenarians, malnutrition, Cerrado, nutritional supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Supplement Group | Experimental | Dietary Supplement: Nutricer Energia Zero-lactoseParticipants received the supplement test (Nutricer Energia Zero-lactose) daily for 3 months |
| Control Group (Multivitamin Mix) | Active comparator | Dietary Supplement: Multivitamin MixParticipants received a multivitamin mix daily for 3 months |
Who may qualify
- Ages
- 90 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Participants aged 90 or over were selected from the database of the Reference Center for Elderly Health Care in Montes Claros, MG .
Key exclusion criteria (1 listed)
- Exclusion criteria included severe obesity, decompensated chronic diseases, or inability/refusal to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutricer Energia Zero-lactoseAlso: Supplement GroupDaily administration of two tablespoons of solubilized in whole milk once a day for 3 months. | Dietary supplement | Supplement Group |
| Multivitamin MixAlso: Control Group (Multivitamin Mix)Daily administration of one multivitamin capsule for 3 months. | Dietary supplement | Control Group (Multivitamin Mix) |
Primary outcome
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.
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.
3 secondary outcomes
Change in Body Weight
Time frame: Baseline and after 12 weeks of supplementation
Change in Body Mass Index
Time frame: Baseline and after 12 weeks of supplementation.
Change in Serum Globulin Levels
Time frame: Baseline and after 12 weeks of supplementation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Malnutrition in the Elderly
Recruiting
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Acute Malnutrition With no Complications
Not yet recruiting
Pilot Study of a Modified Therapeutic Food Compared With a Standard Nutrient Supplement in Young Children in Rural Guatemala
Stunting of Growth, Chronic Malnutrition
RecruitingObservational study
Nutritional Status and Patient Characteristics Upon Length of Stay, Clinical Outcome, and Survival in Older Hospitalized Patients
Geriatric, Malnutrition
Recruiting
The Effect of Volunteer-Engaged Lifestyle Optimisation Via ICOPE on Sarcopenia in Older Adults (VELO-S)
Sarcopenia, Sarcopenia in Elderly
Not yet recruitingObservational study
GNRI and Rectus Femoris Muscle Thickness in Older Patients Undergoing Hip Fracture Surgery
Hip Fracture, Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sérgio H Santos, PhD principal investigator
State University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutricer Energia Zero-lactose and Multivitamin Mix in people with Malnutrition in the Elderly, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline and after 12 weeks of supplementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.