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

NCT04303481 | Completed

• 1 other identifier: 19-062-A
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gut Microbiota

Keywords

Anthropometric index; Biochemical items

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (7)

• The change of fasting glycemia

  Months 0, 1 and 2

• The change of aspartate aminotransferase

  Months 0, 1 and 2

• The change of alanine aminotransferase

  Months 0, 1 and 2

• The change of albumin

  Months 0, 1 and 2

• The change of creatine

  Months 0, 1 and 2

Study Arms (3)

normal diet

OTHER

Other: normal diet

weight loss program kit

EXPERIMENTAL

Other: weight loss program kit

weight loss program kit with A. muciniphila prebiotics

EXPERIMENTAL

Other: weight loss program kit with A. muciniphila prebiotics

Interventions

normal diet OTHER

Control

normal diet

weight loss program kit OTHER

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

weight loss program kit with A. muciniphila prebiotics OTHER

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

weight loss program kit with A. muciniphila prebiotics

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

National Pingtung University of Science and Technology

Pingtung City, Neipu Township, 91201, Taiwan

Location

Study Officials

• Bo-Han Wu

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 11, 2020
• Study Start: August 10, 2019
• Primary Completion: November 3, 2019
• Study Completion: December 31, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

TW (1)