NCT07716839

Brief Summary

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.

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 Aug 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 16, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

Tai Chi ChuanVegan Protein SupplementationBuritiFlexibilityPostural BalanceElderly Health

Outcome Measures

Primary Outcomes (9)

  • Body weight (kg)

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

    Baseline and week 12.

  • Lean body mass percentage (%)

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

    Baseline and week 12

  • Body fat percentage (%)

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

    Baseline and week 12.

  • Handgrip strength (kg)

    Assessment of muscle strength using handgrip strength test with a digital dynamometer and recorded in kilograms (kg).

    Baseline and week 12

  • Plasma glucose concentration (mg/dL)

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

    Baseline and Week 12

  • Percentage of plasma glycosylated hemoglobin (HbA1c) (%)

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

    Baseline and Week 12

  • Plasma LDL cholesterol concentration (mg/dL)

    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)

    Plasma high-density lipoprotein (HDL) cholesterol concentration (mg/dL) will be measured using an enzymatic colorimetric assay.

    Baseline and week 12

  • Plasma total cholesterol concentration (mg/dL)

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

    Baseline and Week 12

Secondary Outcomes (2)

  • Functional balance assessed by the Timed Up and Go (TUG) test

    Baseline and week 12

  • Flexibility assessed by the Sit-and-Reach test

    Baseline and week 12

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants will receive vegan protein supplementation with Nutricer® (based on buriti, rice, and pea), in addition to regular Tai Chi Chuan practice.

Dietary Supplement: Nutricer® SupplementationBehavioral: Tai Chi Chuan program

Placebo Comparator

PLACEBO COMPARATOR

Participants will receive a placebo (maltodextrin), in addition to regular Tai Chi Chuan practice

Other: Maltodextrin (Placebo)Behavioral: Tai Chi Chuan program

Interventions

Nutricer® SupplementationDIETARY_SUPPLEMENT

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

Experimental Group

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

Placebo Comparator

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

Experimental GroupPlacebo Comparator

Eligibility Criteria

Age60 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of Minas Gerais

Montes Claros, Minas Gerais, 39401002, Brazil

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Sérgio H Santos, PhD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 21, 2026

Study Start

August 1, 2025

Primary Completion

January 1, 2026

Study Completion

June 1, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

Locations