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- Klinische proef NCT07716839
Effects of a Buriti Supplement on Body Composition and Function in Older Adults
31 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Minas Gerais
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Montes Claros, Minas Gerais, Brazilië, 39401002
- State University of Minas Gerais
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Placebo-vergelijker: Placebo Comparator
Participants will receive a placebo (maltodextrin), in addition to regular Tai Chi Chuan practice
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Body weight (kg)
Tijdsspanne: 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 (%)
Tijdsspanne: 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 (%)
Tijdsspanne: 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)
Tijdsspanne: Baseline and week 12
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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)
Tijdsspanne: 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) (%)
Tijdsspanne: Baseline and Week 12
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Glycosylated hemoglobin (HbA1c) (%) will be measured in whole blood.
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Baseline and Week 12
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Plasma LDL cholesterol concentration (mg/dL)
Tijdsspanne: Baseline and week 12
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Plasma low-density lipoprotein (LDL) 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 HDL cholesterol concentration (mg/dL)
Tijdsspanne: Baseline and week 12
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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)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Functional balance assessed by the Timed Up and Go (TUG) test
Tijdsspanne: Baseline and week 12
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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
Tijdsspanne: Baseline and week 12
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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
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Sérgio H Santos, PhD, Federal University of Minas Gerais
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 augustus 2025
Primaire voltooiing (Werkelijk)
1 januari 2026
Studie voltooiing (Werkelijk)
1 juni 2026
Studieregistratiedata
Eerst ingediend
16 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
16 juli 2026
Eerst geplaatst (Werkelijk)
21 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 september 2026
Laatste update ingediend die voldeed aan QC-criteria
31 augustus 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 7.662.055
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .