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Clinical Trials/NCT04501601
NCT04501601
Completed
Not Applicable

The Effect of Consuming on Body Composition and Blood Biochemistry Index

TCI Co., Ltd.1 site in 1 country25 target enrollmentAugust 1, 2020
ConditionsGut Microbiota

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gut Microbiota
Sponsor
TCI Co., Ltd.
Enrollment
25
Locations
1
Primary Endpoint
The change of body fat mass
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

To assess the effect of consuming on body composition and blood biochemistry index

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or female aged between 20 and 60 years old
  • Body mass index (BMI) ≥ 24 (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

Outcomes

Primary Outcomes

The change of body fat mass

Time Frame: Change from Baseline body fat mass at 2 months

The body fat mass (kg) was assessed by InBody770.

The change of Triglyceride

Time Frame: Change from Baseline triglyceride at 2 months

Venous blood was sampled to measure concentrations of Triglyceride

The change of LDL-cholesterol

Time Frame: Change from Baseline LDL-cholesterol at 2 months

Venous blood was sampled to measure concentrations of LDL-cholestrol

The change of HDL-cholesterol

Time Frame: Change from Baseline HDL-cholesterol at 2 months

Venous blood was sampled to measure concentrations of HDL-cholestrol

Fecal microbiome analysis

Time Frame: Change from Baseline Fecal microbiome at 2 months

Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.

The change of body mass index (BMI)

Time Frame: Change from Baseline body mass index at 2 months

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.

The change of visceral fat

Time Frame: Change from Baseline visceral fat at 2 months

The visceral fat (10 cm\^2) was assessed by InBody770.

The change of Total cholesterol

Time Frame: Change from Baseline total cholesterol at 2 months

Venous blood was sampled to measure concentrations of Total cholestrol

The change of body fat percentage

Time Frame: Change from Baseline body fat percentage at 2 months

The body fat percentage (%) was assessed by InBody770

Secondary Outcomes

  • The change of white blood cell(Change from Baseline white blood cell at 2 months)
  • The change of fasting glycemia(Change from Baseline fasting glycemia at 2 months)
  • The change of albumin(Change from Baseline albumin at 2 months)
  • The change of aspartate aminotransferase(Change from Baseline aspartate aminotransferase at 2 months)
  • The change of uric acid(Change from Baseline uric acid at 2 months)
  • The change of alanine aminotransferase(Change from Baseline alanine aminotransferase at 2 months)
  • The change of creatinine(Change from Baseline creatinine at 2 months)

Study Sites (1)

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