Efficacy Evaluation of Dai Dai Flower on Body Weight
3. august 2021 oppdatert av: TCI Co., Ltd.
To assess the Dai Dai flower extract on body weight control
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Taichung, Taiwan, 404
- China Medical University
-
-
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
20 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy male or female aged between 20 and 60 years old
- Body mass index (BMI) ≥ 24 (kg/m^2) or body fat mass ≥ 25%
Exclusion Criteria:
- Pregnant or breastfeeding woman
- Implementation in weight loss programs, consumption drugs or supplements for weight control before 3 months of this study
- Participate weight control or fat loss human studies before 3 months of this study
- History of cardiovascular disease, liver disease, kidney disease, endocrine disease, or other major organic diseases (according to subjects reporting).
- Person who has received major surgery or bariatric surgery (according to medical history).
- Person who has received constant drug use.
- People with mental illness
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo-drikk
|
consume 1 bottle (50 mL) per day for 8 weeks
|
|
Eksperimentell: Dai Dai flower drink
|
consume 1 bottle (50 mL) per day for 8 weeks
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The change of body weight
Tidsramme: Change from Baseline body weight at 8 weeks
|
The body weight (kg) was assessed by InBody.
|
Change from Baseline body weight at 8 weeks
|
|
The change of BMI
Tidsramme: Change from Baseline BMI at 8 weeks
|
The BMI was assessed by InBody.
|
Change from Baseline BMI at 8 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The change of body fat mass
Tidsramme: Change from Baseline body fat mass at 8 weeks
|
The body fat mass (kg) was assessed by InBody.
|
Change from Baseline body fat mass at 8 weeks
|
|
The change of visceral fat mass
Tidsramme: Change from Baseline visceral fat mass at 8 weeks
|
The visceral fat mass (kg) was assessed by InBody.
|
Change from Baseline visceral fat mass at 8 weeks
|
|
The change of waist-hip ratio
Tidsramme: Change from Baseline waist-hip ratio at 8 weeks
|
The waist-hip ratio was assessed by measuring tape.
|
Change from Baseline waist-hip ratio at 8 weeks
|
|
The change of basal metabolic rate
Tidsramme: Change from Baseline basal metabolic rate at 8 weeks
|
The basal metabolic rate was assessed by InBody.
|
Change from Baseline basal metabolic rate at 8 weeks
|
|
The change of AST
Tidsramme: Change from Baseline AST at 8 weeks
|
Venous blood was sampled to measure concentrations of aspartate transaminase (AST)
|
Change from Baseline AST at 8 weeks
|
|
The change of ALT
Tidsramme: Change from Baseline ALT at 8 weeks
|
Venous blood was sampled to measure concentrations of alanine aminotransferase (ALT)
|
Change from Baseline ALT at 8 weeks
|
|
The change of Creatinine
Tidsramme: Change from Baseline creatinine at 8 weeks
|
Venous blood was sampled to measure concentrations of creatinine
|
Change from Baseline creatinine at 8 weeks
|
|
The change of BUN
Tidsramme: Change from Baseline BUN at 8 weeks
|
Venous blood was sampled to measure concentrations of blood urea nitrogen (BUN)
|
Change from Baseline BUN at 8 weeks
|
|
The change of fasting glycemia
Tidsramme: Change from Baseline fasting glycemia at 8 weeks
|
Venous blood was sampled to measure concentrations of fasting glycemia
|
Change from Baseline fasting glycemia at 8 weeks
|
|
The change of total cholesterol
Tidsramme: Change from Baseline total cholesterol at 8 weeks
|
Venous blood was sampled to measure concentrations of total cholesterol
|
Change from Baseline total cholesterol at 8 weeks
|
|
The change of triglyceride
Tidsramme: Change from Baseline triglyceride at 8 weeks
|
Venous blood was sampled to measure concentrations of triglyceride
|
Change from Baseline triglyceride at 8 weeks
|
|
The change of HDL-cholesterol
Tidsramme: Change from Baseline HDL-cholesterol at 8 weeks
|
Venous blood was sampled to measure concentrations of HDL-cholesterol
|
Change from Baseline HDL-cholesterol at 8 weeks
|
|
The change of LDL-cholesterol
Tidsramme: Change from Baseline LDL-cholesterol at 8 weeks
|
Venous blood was sampled to measure concentrations of LDL-cholesterol
|
Change from Baseline LDL-cholesterol at 8 weeks
|
|
The change of insulin
Tidsramme: Change from Baseline insulin at 8 weeks
|
Venous blood was sampled to measure concentrations of insulin
|
Change from Baseline insulin at 8 weeks
|
|
The change of adiponectin
Tidsramme: Change from Baseline adiponectin at 8 weeks
|
Venous blood was sampled to measure concentrations of adiponectin
|
Change from Baseline adiponectin at 8 weeks
|
|
The change of leptin
Tidsramme: Change from Baseline leptin at 8 weeks
|
Venous blood was sampled to measure concentrations of leptin
|
Change from Baseline leptin at 8 weeks
|
|
The change of IFN-γ
Tidsramme: Change from Baseline IFN-γ at 8 weeks
|
Venous blood was sampled to measure concentrations of IFN-γ
|
Change from Baseline IFN-γ at 8 weeks
|
|
The change of IL-2
Tidsramme: Change from Baseline IL-2 at 8 weeks
|
Venous blood was sampled to measure concentrations of IL-2
|
Change from Baseline IL-2 at 8 weeks
|
|
The change of IL-1beta
Tidsramme: Change from Baseline IL-1beta at 8 weeks
|
Venous blood was sampled to measure concentrations of IL-1beta
|
Change from Baseline IL-1beta at 8 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
4. januar 2021
Primær fullføring (Faktiske)
6. mars 2021
Studiet fullført (Faktiske)
15. juni 2021
Datoer for studieregistrering
Først innsendt
29. desember 2020
Først innsendt som oppfylte QC-kriteriene
29. desember 2020
Først lagt ut (Faktiske)
5. januar 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMUH109-REC1-161
Legemiddel- og utstyrsinformasjon, studiedokumenter
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