- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07716839
Effects of a Buriti Supplement on Body Composition and Function in Older Adults
31 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Minas Gerais
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Montes Claros, Minas Gerais, Brasilien, 39401002
- State University of Minas Gerais
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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-jämförare: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body weight (kg)
Tidsram: Baseline and week 12.
|
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 (%)
Tidsram: 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.
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Baseline and week 12
|
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Body fat percentage (%)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline and Week 12
|
Plasma glucose concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
|
Baseline and Week 12
|
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Percentage of plasma glycosylated hemoglobin (HbA1c) (%)
Tidsram: Baseline and Week 12
|
Glycosylated hemoglobin (HbA1c) (%) will be measured in whole blood.
|
Baseline and Week 12
|
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Plasma LDL cholesterol concentration (mg/dL)
Tidsram: Baseline and week 12
|
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)
Tidsram: 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)
Tidsram: Baseline and Week 12
|
Plasma total cholesterol concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
|
Baseline and Week 12
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Functional balance assessed by the Timed Up and Go (TUG) test
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Sérgio H Santos, PhD, Federal University of Minas Gerais
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 augusti 2025
Primärt slutförande (Faktisk)
1 januari 2026
Avslutad studie (Faktisk)
1 juni 2026
Studieregistreringsdatum
Först inskickad
16 juli 2026
Först inskickad som uppfyllde QC-kriterierna
16 juli 2026
Första postat (Faktisk)
21 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 augusti 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 7.662.055
Läkemedels- och apparatinformation, studiedokument
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