- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07716839
Effects of a Buriti Supplement on Body Composition and Function in Older Adults
31. august 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Minas Gerais
-
Montes Claros, Minas Gerais, Brasil, 39401002
- State University of Minas Gerais
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental Group
Participants will receive vegan protein supplementation with Nutricer® (based on buriti, rice, and pea), in addition to regular Tai Chi Chuan practice.
|
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 komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body weight (kg)
Tidsramme: Baseline and week 12.
|
Body weight will be measured using a calibrated digital scale and recorded in kilograms (kg).
|
Baseline and week 12.
|
|
Lean body mass percentage (%)
Tidsramme: 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.
|
Baseline and week 12
|
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Body fat percentage (%)
Tidsramme: Baseline and week 12.
|
Body fat percentage will be assessed using bioelectrical impedance analysis (BIA) and expressed as a percentage of total body mass.
|
Baseline and week 12.
|
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Handgrip strength (kg)
Tidsramme: Baseline and week 12
|
Assessment of muscle strength using handgrip strength test with a digital dynamometer and recorded in kilograms (kg).
|
Baseline and week 12
|
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Plasma glucose concentration (mg/dL)
Tidsramme: Baseline and Week 12
|
Plasma glucose concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
|
Baseline and Week 12
|
|
Percentage of plasma glycosylated hemoglobin (HbA1c) (%)
Tidsramme: Baseline and Week 12
|
Glycosylated hemoglobin (HbA1c) (%) will be measured in whole blood.
|
Baseline and Week 12
|
|
Plasma LDL cholesterol concentration (mg/dL)
Tidsramme: 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
|
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Plasma HDL cholesterol concentration (mg/dL)
Tidsramme: Baseline and week 12
|
Plasma high-density lipoprotein (HDL) cholesterol concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
|
Baseline and week 12
|
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Plasma total cholesterol concentration (mg/dL)
Tidsramme: Baseline and Week 12
|
Plasma total cholesterol concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
|
Baseline and Week 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional balance assessed by the Timed Up and Go (TUG) test
Tidsramme: 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.
|
Baseline and week 12
|
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Flexibility assessed by the Sit-and-Reach test
Tidsramme: 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.
|
Baseline and week 12
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Sérgio H Santos, PhD, Federal University of Minas Gerais
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2025
Primær fullføring (Faktiske)
1. januar 2026
Studiet fullført (Faktiske)
1. juni 2026
Datoer for studieregistrering
Først innsendt
16. juli 2026
Først innsendt som oppfylte QC-kriteriene
16. juli 2026
Først lagt ut (Faktiske)
21. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 7.662.055
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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