- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05290519
Comparison of Plant-based or Animal-based Protein on Anthropocentric and Metabolic Parameters in Obese Subjects
13. marts 2022 opdateret af: National Taiwan Normal University
The investigators will try to evaluate the effects of substitution of dietary animal protein by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in obese subjects.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
According to the survey by the Ministry of Health and Welfare, the proportion of obese male adolescents in Taiwan has been increasing year by year.
Obesity is associated with chronic low-grade inflammation.
Obese people prefer to intake foods containing higher levels of advanced glycation end products (AGEs).
High intake of dietary AGEs (dAGEs) results in abdominal obesity, and shows positive correlation with body mass index (BMI) and waist circumference.
When a large amount of AGEs accumulates in the body, inflammation usually occurs.
Therefore, reducing dAGEs intake prevents the incidence of obesity, chronic diseases and aging.
Black beans are high in protein.
The black bean coats contain high level of anthocyanins.
Previous studies demonstrated the biological functions of anthocyanins on blood lipid regulation, inflammation, and also inhibition of AGEs formation.
Compared with meat (beef, pork, lamb, chicken, and seafood), the plant protein source, soy milk, under the same protein content showed significantly lower dAGE.
In this study, the investigators will try to eveluate the effects of substitution of dietary animal protein by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in obese subjects.
This will be a randomized crossover interventional trial for 16 weeks: 0 to 4 weeks will be run-in period, 4 to 8 weeks and 12 to 16 weeks will be the soy milk or meat intervention period, and the between of two interventions (8 to 12 weeks) will be washout period.
The body composition, blood pressure and AGE level will be measured.
The blood, urine and feces sample will be collected for biochemical analysis and gut microbiome.
The investigators expect the results could support the promotion of plant protein as part of dietary protein source to improve abnormal anthropometric and metabolic parameters in obese subjects.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Wan-Ju Yeh
- Telefonnummer: 886277496988
- E-mail: wandayeh@ntnu.edu.tw
Studiesteder
-
-
-
Taipei, Taiwan, 106
- Rekruttering
- National Taiwan Normal University
-
Kontakt:
- Shu-Man Pan
- Telefonnummer: 886277491903
- E-mail: ntnurec@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 64 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 20 to 64 year male or female
- 27 <= BMI < 35 or waist circumference male >= 90 cm/female >= 80 cm
- fasting blood glucose: 100-125 mg/dL
Exclusion Criteria:
- Hypertension, cardiovascular disease, endocrine disease, acute and chronic liver and kidney disease, mental disease, binge or anorexia, or long-term drug use
- Consume probiotics, prebiotics, antibiotics or weight loss drugs regularly for the past month
- Try to lose weight and do resistance exercise regularly for the past month
- Allergic to soy products
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Group A
plant protein for 4 weeks than animal protein for 4 weeks
|
plant protein: 2 bottle of black soy milk (400 mL/bottle) for 4 weeks animal protein: pork dished for 4 weeks
|
Eksperimentel: Group B
animal protein for 4 weeks than plant protein for 4 weeks
|
plant protein: 2 bottle of black soy milk (400 mL/bottle) for 4 weeks animal protein: pork dished for 4 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
change from 4week blood advanced glycation end products level at 8 week
Tidsramme: 4, 8 week
|
blood AGEs level will be measured before and after intervention
|
4, 8 week
|
change from 12 week blood advanced glycation end products level at 16 week
Tidsramme: 12, 16 week
|
blood AGEs level will be measured before and after intervention
|
12, 16 week
|
change from 4 week blood leptin level at 8 week
Tidsramme: 4, 8 week
|
blood leptin level will be measured before and after intervention
|
4, 8 week
|
change from 12 week blood leptin level at 16 week
Tidsramme: 12, 16 week
|
blood leptin level will be measured before and after intervention
|
12, 16 week
|
change from 4 week blood adiponectin level at 8 week
Tidsramme: 4, 8 week
|
blood leptin level will be measured before and after intervention
|
4, 8 week
|
change from 12 week blood adiponectin level at 16 week
Tidsramme: 12, 16 week
|
blood leptin level will be measured before and after intervention
|
12, 16 week
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Wan-Ju Yeh, National Taiwan Normal University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2022
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
31. december 2022
Datoer for studieregistrering
Først indsendt
1. marts 2022
Først indsendt, der opfyldte QC-kriterier
13. marts 2022
Først opslået (Faktiske)
22. marts 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. marts 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NTNU
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
IPD will be published in journals
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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