The Effect of Consuming Enzymes and Prebiotics on Body Composition and Blood Biochemical Index
10. marts 2020 opdateret af: TCI Co., Ltd.
To assess the effects of consuming enzymes and prebiotics on improvement of weight loss and biochemical parameters
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
88
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Neipu Township
-
Pingtung, Neipu Township, Taiwan, 91201
- National Pingtung University of Science and Technology
-
-
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 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female aged between 20 and 50 years old
- Body mass index (BMI) ≥ 22 (kg/m^2) or body fat mass: male > 25%, female > 30%
- Prohibitions on other nutritional supplements (probiotics and prebiotics) before two weeks of the study
- Abidance by the similar diet and exercise habits over the study.
Exclusion Criteria:
- Pregnant or breastfeeding woman
- Menopausal woman
- Diabetes mellitus
- Implementation in weight loss programs before a half year of this study
- Metabolic disorders
- Kidney diseases
- Liver diseases
- Cardiovascular diseases
- Nervous system diseases
- Gastrointestinal diseases
- Heavy drinking or constant drug use.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: normal diet
|
Control
|
|
Eksperimentel: weight loss program kit
|
Subjects should adhere to the eating plan, which contained the following kit components : four flavors of collagen drinks [i.e., Caviar Collagen Enzyme Drink, Collagen Enzyme Drinks (Peach Taste), Collagen Enzyme Drinks (Grape Fruit Taste), Saussurea involucrata Enzyme Drink (Litchi Taste)], six flavors of mike shakes (i.e., Corn Soup Mike Shake, Strawberry Mike Shake, Chocolate Mike Shake, Vanilla Mike Shake, Banana Mike Shakes, Matcha Mike Shakes), Fruit and Vegitable Congee, and Botanical Liquid Sachet.
|
|
Eksperimentel: weight loss program kit with A. muciniphila prebiotics
|
Subjects should adhere to the eating plan, which contained the following kit components : four flavors of collagen drinks [i.e., Caviar Collagen Enzyme Drink, Collagen Enzyme Drinks (Peach Taste), Collagen Enzyme Drinks (Grape Fruit Taste), Saussurea involucrata Enzyme Drink (Litchi Taste)], six flavors of mike shakes (i.e., Corn Soup Mike Shake, Strawberry Mike Shake, Chocolate Mike Shake, Vanilla Mike Shake, Banana Mike Shakes, Matcha Mike Shakes), Fruit and Vegitable Congee, Botanical Liquid Sachet, and Probiotics Liquid Sachet
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The change of body fat mass
Tidsramme: Months 0, 1 and 2
|
The body fat mass (kg) was assessed by InBody770.
|
Months 0, 1 and 2
|
|
The change of Triglyceride
Tidsramme: Months 0, 1 and 2
|
Venous blood was sampled to measure concentrations of Triglyceride
|
Months 0, 1 and 2
|
|
The change of Total cholestrol
Tidsramme: Months 0, 1 and 2
|
Venous blood was sampled to measure concentrations of Total cholestrol
|
Months 0, 1 and 2
|
|
The change of HDL-cholestrol
Tidsramme: Months 0, 1 and 2
|
Venous blood was sampled to measure concentrations of HDL-cholestrol
|
Months 0, 1 and 2
|
|
The change of LDL-cholestrol
Tidsramme: Months 0, 1 and 2
|
Venous blood was sampled to measure concentrations of LDL-cholestrol
|
Months 0, 1 and 2
|
|
Fecal microbiome analysis
Tidsramme: Months 0, 1 and 2
|
Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.
|
Months 0, 1 and 2
|
|
The change of body mass index (BMI)
Tidsramme: Months 0, 1 and 2
|
BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) were assessed by InBody770.
|
Months 0, 1 and 2
|
|
The change of body fat percentage
Tidsramme: Months 0, 1 and 2
|
The body fat percentage (%) was assessed by InBody770.
|
Months 0, 1 and 2
|
|
The change of visceral fat
Tidsramme: Months 0, 1 and 2
|
The visceral fat (10 cm^2) was assessed by InBody770.
|
Months 0, 1 and 2
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The change of fasting glycemia
Tidsramme: Months 0, 1 and 2
|
Venous blood was sampled to measure concentrations of fasting glycemia
|
Months 0, 1 and 2
|
|
The change of aspartate aminotransferase
Tidsramme: Months 0, 1 and 2
|
Venous blood was sampled to measure concentrations of aspartate aminotransferase
|
Months 0, 1 and 2
|
|
The change of alanine aminotransferase
Tidsramme: Months 0, 1 and 2
|
Venous blood was sampled to measure concentrations of alanine aminotransferase
|
Months 0, 1 and 2
|
|
The change of albumin
Tidsramme: Months 0, 1 and 2
|
Venous blood was sampled to measure concentrations of albumin
|
Months 0, 1 and 2
|
|
The change of creatine
Tidsramme: Months 0, 1 and 2
|
Venous blood was sampled to measure concentrations of creatine
|
Months 0, 1 and 2
|
|
The change of uric acid
Tidsramme: Months 0, 1 and 2
|
Venous blood was sampled to measure concentrations of uric acid
|
Months 0, 1 and 2
|
|
The change of white blood cell
Tidsramme: Months 0, 1 and 2
|
Venous blood was sampled to measure concentrations of white blood cell
|
Months 0, 1 and 2
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
10. august 2019
Primær færdiggørelse (Faktiske)
3. november 2019
Studieafslutning (Faktiske)
31. december 2019
Datoer for studieregistrering
Først indsendt
3. marts 2020
Først indsendt, der opfyldte QC-kriterier
10. marts 2020
Først opslået (Faktiske)
11. marts 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 19-062-A
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 .