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

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

Study Overview

• Status: Completed
• Conditions: Gut Microbiota
• Intervention / Treatment: Other: normal diet; Other: weight loss program kit; Other: weight loss program kit with A. muciniphila prebiotics

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Neipu Township
    • Pingtung, Neipu Township, Taiwan, 91201
      • National Pingtung University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: normal diet	Other: normal diet; Control
Experimental: weight loss program kit	Other: 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.
Experimental: weight loss program kit with A. muciniphila prebiotics	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of body fat mass	The body fat mass (kg) was assessed by InBody770.	Months 0, 1 and 2
The change of Triglyceride	Venous blood was sampled to measure concentrations of Triglyceride	Months 0, 1 and 2
The change of Total cholestrol	Venous blood was sampled to measure concentrations of Total cholestrol	Months 0, 1 and 2
The change of HDL-cholestrol	Venous blood was sampled to measure concentrations of HDL-cholestrol	Months 0, 1 and 2
The change of LDL-cholestrol	Venous blood was sampled to measure concentrations of LDL-cholestrol	Months 0, 1 and 2
Fecal microbiome analysis	Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.	Months 0, 1 and 2
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
The change of body fat percentage	The body fat percentage (%) was assessed by InBody770.	Months 0, 1 and 2
The change of visceral fat	The visceral fat (10 cm^2) was assessed by InBody770.	Months 0, 1 and 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of fasting glycemia	Venous blood was sampled to measure concentrations of fasting glycemia	Months 0, 1 and 2
The change of aspartate aminotransferase	Venous blood was sampled to measure concentrations of aspartate aminotransferase	Months 0, 1 and 2
The change of alanine aminotransferase	Venous blood was sampled to measure concentrations of alanine aminotransferase	Months 0, 1 and 2
The change of albumin	Venous blood was sampled to measure concentrations of albumin	Months 0, 1 and 2
The change of creatine	Venous blood was sampled to measure concentrations of creatine	Months 0, 1 and 2
The change of uric acid	Venous blood was sampled to measure concentrations of uric acid	Months 0, 1 and 2
The change of white blood cell	Venous blood was sampled to measure concentrations of white blood cell	Months 0, 1 and 2

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2019
• Primary Completion (Actual): November 3, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Anthropometric index; Biochemical items
• Other Study ID Numbers: 19-062-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No