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OpenTrials
Completed

NCT Number: NCT07716839

Effects of a Buriti Suplpement on Body Composition and Function in Older Adults

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.

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Key information

Conditions

Aging Atrophy Malnutrition Elderly Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

State University of Minas Gerais

Montes Claros, Minas Gerais, 39401002, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nutricer® Supplementation

Dietary Supplement

Vegan protein supplement based on buriti (Mauritia flexuosa), rice and pea.

Maltodextrin (Placebo)

Other

Placebo supplement (maltodextrin), administered daily during the study period.

Tai Chi Chuan program

Behavioral

Participants will participate in a supervised Tai Chi Chuan program consisting of structured sessions led by a qualified instructor throughout the intervention period.

Primary outcomes

  1. Body weight (kg)

    Time frame: Baseline and week 12.

    Body weight will be measured using a calibrated digital scale and recorded in kilograms (kg).

  2. Lean body mass percentage (%)

    Time frame: Baseline and week 12

    Lean body mass percentage will be assessed using bioelectrical impedance analysis (BIA) and expressed as a percentage of total body mass.

  3. Body fat percentage (%)

    Time frame: Baseline and week 12.

    Body fat percentage will be assessed using bioelectrical impedance analysis (BIA) and expressed as a percentage of total body mass.

  4. 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).

  5. Plasma glucose concentration (mg/dL)

    Time frame: Baseline and Week 12

    Plasma glucose concentration (mg/dL) will be measured using an enzymatic colorimetric assay.

  6. Percentage of plasma glycosylated hemoglobin (HbA1c) (%)

    Time frame: Baseline and Week 12

    Glycosylated hemoglobin (HbA1c) (%) will be measured in whole blood.

  7. 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.

  8. 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.

  9. Plasma total cholesterol concentration (mg/dL)

    Time frame: Baseline and Week 12

    Plasma total cholesterol concentration (mg/dL) will be measured using an enzymatic colorimetric assay.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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