- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01532375
Kochujang, a Fermented Soybean-based Red Pepper Paste, Decreases Visceral Fat and Improves Blood Lipid Profiles in Overweight Adults
Kochujang Decreases Visceral Fat and Improves Lipids Profiles
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The aim of this study was to evaluate the efficacy of KCJ supplementation on anthropometric parameters, visceral fat/subcutaneous fat, and blood lipid profiles in overweight subjects.
Sixty overweight subjects with BMI >25 kg/m2 and waist-hip-ratio (WHR) ≥ 0.90 for men and ≥ 0.85 for women were randomly assigned to either KCJ supplement (n=30, 32 g/day) or placebo (n=30, 32 g/day) group for 12 weeks.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- BMI >25kg/m2 and 2)Waist-Hip Ratio (WHR): WHR> 0.90(male), WHR>0.85(female)
Exclusion Criteria:
- lipid metabolic disorders
- >10% changes in body weight in the past 3 months
- Cardiovascular disease such as arrhythmia, heart failure, myocardial infarction, and wearing pacemaker
- Allergy or hypersensitivity to any of the ingredients in the test products - History of reaction to any of the experimental products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- Participation in other clinical trials within the past 2 months
Abnormal hepatic liver function, renal disease such as acute
- chronic renal failure, nephrotic syndrome
- Use of anti-psychosis drug therapy within 2 months
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- History of alcohol or substance abuse
- Pregnancy or breastfeeding
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Kochujang(32g)
|
Kochujang (32g/day) for 12weeks.
|
Placebo komparator: placebo(32g)
|
placebo(32g/day) for 12weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Visceral fat
Tidsramme: after 12 weeks of consumption
|
after 12 weeks of consumption
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Body Mass Index
Tidsramme: after 12 weeks of consumption
|
after 12 weeks of consumption
|
Subcutaneous fat
Tidsramme: after 12weeks
|
after 12weeks
|
Triglyceride
Tidsramme: after 12week of consumption
|
after 12week of consumption
|
Atherosclerosis index
Tidsramme: after 12weeks of consumption
|
after 12weeks of consumption
|
Apolipoprotein
Tidsramme: after 12weeks of consumption
|
after 12weeks of consumption
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Soo-Wan Chae, Ph.D, MD, Chonbuk National University Hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CUH_2008_AT_4
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Kliniske forsøg med Kochujang
-
Chonbuk National University HospitalAfsluttetHyperlipidæmiKorea, Republikken
-
Chonbuk National University HospitalUkendtHyperlipidæmiKorea, Republikken