Effects of Fried Foods Prepared in Palm Oil Blended With Canola Oil Containing Surfactants and Green Tea Extract
Effects of Fried Foods Prepared in Palm Oil Blended With Canola Oil Containing Surfactants and Green Tea Extract on Postprandial Triglyceride Levels: A Double-blinded Randomized Controlled Clinical Trial
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Bangkok, Thailand, 10330
- Chulalongkorn University
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Male or female participants aged 18-60 years.
- Participants with fasting triglyceride levels <150 mg/dL (after fasting for at least 8-12 hours before blood collection).
- Participants without a history of cardiovascular disease, diabetes mellitus, thyroid disease, cancer, liver disease, or kidney disease.
- Participants who are able to read and write.
- Participants who voluntarily agree to participate after receiving information regarding the study objectives, procedures, potential risks, and expected benefits; are able to comply with the study protocol; and provide written informed consent.
Exclusion Criteria:
- Participants with a history of allergy or adverse reactions, such as skin, respiratory, or gastrointestinal symptoms, after consuming foods containing canola oil, polyglycerol esters of fatty acids (PGEs), green tea extract, palm oil, or banana.
- Participants who have consumed medications, dietary supplements, herbal products, or foods that may affect metabolism, such as weight-loss products or L-carnitine, within 2 weeks prior to enrollment.
- Participants who regularly use medications that may affect lipid metabolism or blood lipid levels, such as corticosteroids or lipid-lowering agents.
- Participants with serious underlying diseases or poorly controlled medical conditions, such as cancer, cardiovascular disease, or immunodeficiency disorders.
- Participants with impaired liver or kidney function, defined as AST/ALT levels >3 times the upper limit of normal or kidney disease with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m².
- Female participants who are pregnant or breastfeeding.
- Participants who regularly smoke.
- Participants who regularly consume alcohol.
- Participants who are currently participating in another research study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Fried Foods Prepared in Palm Oil Blended With Canola Oil Containing Surfactants and Green Tea Extrac
Take fried foods prepared in palm oil blended with canola oil containing surfactants and green tea extract 7 pieces.
|
Take fried foods prepared in palm oil blended with canola oil containing surfactants and green tea extract 7 pieces.
|
|
Aktiv komparator: Control group
Take fried foods prepared in palm oil 7 pieces
|
Take fried foods prepared in palm oil 7 pieces.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postprandial triglyceride
Tidsramme: 5 hours
|
Postprandial triglyceride in blood
|
5 hours
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Total cholesterol in blood
Tidsramme: 5 hours
|
5 hours
|
|
High Density Lipoprotein in blood
Tidsramme: 5 hours
|
5 hours
|
|
Low Density Lipoprotein in blood
Tidsramme: 5 hours
|
5 hours
|
|
Fasting blood glucose
Tidsramme: 5 hours
|
5 hours
|
|
Creatinine in blood
Tidsramme: 5 hours
|
5 hours
|
|
Blood Urea Nitrogen
Tidsramme: 5 hours
|
5 hours
|
|
Aspartate Aminotransferase in blood
Tidsramme: 5 hours
|
5 hours
|
|
Alanine Aminotransferase in blood
Tidsramme: 5 hours
|
5 hours
|
|
Alkaline Phosphatase in blood
Tidsramme: 5 hours
|
5 hours
|
|
Plasma antioxidant
Tidsramme: 5 hours
|
5 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- EC25137-20
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .