- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07716839
Effects of a Buriti Supplement on Body Composition and Function in Older Adults
August 31, 2026 updated by: Sergio Henrique Sousa Santos, Federal University of Minas Gerais
Effects of "Nutricer®" Vegan Protein Supplementation Based on Buriti (Mauritia Flexuosa), Rice, and Pea on Body Composition, Flexibility, Balance, and Dietary Frequency in Elderly Tai Chi Chuan Practitioners: A Placebo-Controlled Clinical Trial
Aging is a natural process commonly associated with loss of muscle mass, reduced flexibility, and impaired balance, directly affecting the quality of life of older adults.
Tai Chi Chuan, a traditional mind-body practice, has been shown to improve balance, flexibility, and overall well-being in elderly populations.
In addition, nutritional supplementation may enhance these effects, particularly when based on plant-derived functional compounds.This study aims to evaluate the effects of vegan protein supplementation with Nutricer®-based on buriti (Mauritia flexuosa), rice, and pea-on body composition, muscle strength, flexibility, balance, and dietary frequency in elderly women practicing Tai Chi Chuan.
This is a placebo-controlled clinical trial involving 40 elderly female participants, randomly assigned into two groups: an experimental group (n = 20), receiving Nutricer® supplementation, and a control group (n = 20), receiving a placebo (maltodextrin), both alongside regular Tai Chi Chuan practice.Buriti is known for its antioxidant and anti-inflammatory properties, which may contribute to the preservation of muscle and functional health.
It is expected that the combination of vegan protein supplementation and Tai Chi Chuan practice will result in significant improvements in functional health, providing a natural, accessible, and safe strategy for healthy aging.
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
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Minas Gerais
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Montes Claros, Minas Gerais, Brazil, 39401002
- State University of Minas Gerais
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female participants aged 60 years or older
- Participation in a Tai Chi Chuan program (at least twice per week, 60-minute sessions)
- Commitment to remain in the study throughout the intervention period (e.g., 12 weeks)
- Ability to understand and respond to questionnaires and perform the proposed physical tests
- Willingness to participate and provide written informed consent (Informed Consent Form)
Exclusion Criteria:
• Current use of protein supplements, vitamins, or similar products to the study supplement
- Medical contraindications to performing light to moderate physical exercise
- Diseases or conditions that significantly impair mobility (e.g., severe stroke sequelae, advanced Parkinson's disease)
- Moderate to severe cognitive impairment (e.g., dementia)
- Irregular participation in Tai Chi Chuan sessions (absence greater than 20% during the intervention period)
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Participants will receive vegan protein supplementation with Nutricer® (based on buriti, rice, and pea), in addition to regular Tai Chi Chuan practice.
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Vegan protein supplement based on buriti (Mauritia flexuosa), rice and pea.
Participants will participate in a supervised Tai Chi Chuan program consisting of structured sessions led by a qualified instructor throughout the intervention period.
|
|
Placebo Comparator: Placebo Comparator
Participants will receive a placebo (maltodextrin), in addition to regular Tai Chi Chuan practice
|
Participants will participate in a supervised Tai Chi Chuan program consisting of structured sessions led by a qualified instructor throughout the intervention period.
Placebo supplement (maltodextrin), administered daily during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body weight (kg)
Time Frame: Baseline and week 12.
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Body weight will be measured using a calibrated digital scale and recorded in kilograms (kg).
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Baseline and week 12.
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Lean body mass percentage (%)
Time Frame: Baseline and week 12
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Lean body mass percentage will be assessed using bioelectrical impedance analysis (BIA) and expressed as a percentage of total body mass.
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Baseline and week 12
|
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Body fat percentage (%)
Time Frame: Baseline and week 12.
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Body fat percentage will be assessed using bioelectrical impedance analysis (BIA) and expressed as a percentage of total body mass.
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Baseline and week 12.
|
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Handgrip strength (kg)
Time Frame: Baseline and week 12
|
Assessment of muscle strength using handgrip strength test with a digital dynamometer and recorded in kilograms (kg).
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Baseline and week 12
|
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Plasma glucose concentration (mg/dL)
Time Frame: Baseline and Week 12
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Plasma glucose concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
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Baseline and Week 12
|
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Percentage of plasma glycosylated hemoglobin (HbA1c) (%)
Time Frame: Baseline and Week 12
|
Glycosylated hemoglobin (HbA1c) (%) will be measured in whole blood.
|
Baseline and Week 12
|
|
Plasma LDL cholesterol concentration (mg/dL)
Time Frame: Baseline and week 12
|
Plasma low-density lipoprotein (LDL) cholesterol concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
|
Baseline and week 12
|
|
Plasma HDL cholesterol concentration (mg/dL)
Time Frame: Baseline and week 12
|
Plasma high-density lipoprotein (HDL) cholesterol concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
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Baseline and week 12
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Plasma total cholesterol concentration (mg/dL)
Time Frame: Baseline and Week 12
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Plasma total cholesterol concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
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Baseline and Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional balance assessed by the Timed Up and Go (TUG) test
Time Frame: Baseline and week 12
|
Functional balance will be assessed using the Timed Up and Go (TUG) test.
Participants will be instructed to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
The time required to complete the test will be recorded in seconds, with lower times indicating better functional mobility and balance performance.
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Baseline and week 12
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Flexibility assessed by the Sit-and-Reach test
Time Frame: Baseline and week 12
|
Flexibility will be assessed using the sit-and-reach test.
Participants will perform the test according to standardized procedures, and the maximum distance reached will be recorded in centimeters.
Higher values indicate greater flexibility.
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Baseline and week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sérgio H Santos, PhD, Federal 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)
August 1, 2025
Primary Completion (Actual)
January 1, 2026
Study Completion (Actual)
June 1, 2026
Study Registration Dates
First Submitted
July 16, 2026
First Submitted That Met QC Criteria
July 16, 2026
First Posted (Actual)
July 21, 2026
Study Record Updates
Last Update Posted (Actual)
September 2, 2026
Last Update Submitted That Met QC Criteria
August 31, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7.662.055
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.