The Effect of Consuming Enzymes and Prebiotics on Body Composition and Blood Biochemical Index

Gut Microbiota Clinical Trial

Official title:

The Effect of Consuming Enzymes and Prebiotics on Body Composition and Blood Biochemical Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303481
• Other study ID #: 19-062-A
• Status: Completed
• Phase: N/A
• Start date: August 10, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the effects of consuming enzymes and prebiotics on improvement of weight loss and biochemical parameters

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 31, 2019
• Est. primary completion date: November 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gut Microbiota

Intervention

Other:
• normal diet
Control
• 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.
• 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

Locations

Country	Name	City	State
Taiwan	National Pingtung University of Science and Technology	Pingtung	Neipu Township

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of body fat mass	The body fat mass (kg) was assessed by InBody770.	Months 0, 1 and 2
Primary	The change of Triglyceride	Venous blood was sampled to measure concentrations of Triglyceride	Months 0, 1 and 2
Primary	The change of Total cholestrol	Venous blood was sampled to measure concentrations of Total cholestrol	Months 0, 1 and 2
Primary	The change of HDL-cholestrol	Venous blood was sampled to measure concentrations of HDL-cholestrol	Months 0, 1 and 2
Primary	The change of LDL-cholestrol	Venous blood was sampled to measure concentrations of LDL-cholestrol	Months 0, 1 and 2
Primary	Fecal microbiome analysis	Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.	Months 0, 1 and 2
Primary	The change of body mass index (BMI)	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
Primary	The change of body fat percentage	The body fat percentage (%) was assessed by InBody770.	Months 0, 1 and 2
Primary	The change of visceral fat	The visceral fat (10 cm^2) was assessed by InBody770.	Months 0, 1 and 2
Secondary	The change of fasting glycemia	Venous blood was sampled to measure concentrations of fasting glycemia	Months 0, 1 and 2
Secondary	The change of aspartate aminotransferase	Venous blood was sampled to measure concentrations of aspartate aminotransferase	Months 0, 1 and 2
Secondary	The change of alanine aminotransferase	Venous blood was sampled to measure concentrations of alanine aminotransferase	Months 0, 1 and 2
Secondary	The change of albumin	Venous blood was sampled to measure concentrations of albumin	Months 0, 1 and 2
Secondary	The change of creatine	Venous blood was sampled to measure concentrations of creatine	Months 0, 1 and 2
Secondary	The change of uric acid	Venous blood was sampled to measure concentrations of uric acid	Months 0, 1 and 2
Secondary	The change of white blood cell	Venous blood was sampled to measure concentrations of white blood cell	Months 0, 1 and 2