The Effect of Consuming on Body Composition and Blood Biochemistry Index

Gut Microbiota Clinical Trial

Official title:

The Effect of Consuming on Body Composition and Blood Biochemistry Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501601
• Other study ID #: 20-039-A
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

• Heavy drinking or constant drug use.

Related Conditions & MeSH terms

• Gut Microbiota

Intervention

Dietary Supplement:
• Fruit and vegetable solid drink
weight loss program supplement

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.	Change from Baseline body fat mass at 2 months
Primary	The change of Triglyceride	Venous blood was sampled to measure concentrations of Triglyceride	Change from Baseline triglyceride at 2 months
Primary	The change of Total cholesterol	Venous blood was sampled to measure concentrations of Total cholestrol	Change from Baseline total cholesterol at 2 months
Primary	The change of HDL-cholesterol	Venous blood was sampled to measure concentrations of HDL-cholestrol	Change from Baseline HDL-cholesterol at 2 months
Primary	The change of LDL-cholesterol	Venous blood was sampled to measure concentrations of LDL-cholestrol	Change from Baseline LDL-cholesterol at 2 months
Primary	Fecal microbiome analysis	Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.	Change from Baseline Fecal microbiome at 2 months
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.	Change from Baseline body mass index at 2 months
Primary	The change of body fat percentage	The body fat percentage (%) was assessed by InBody770	Change from Baseline body fat percentage at 2 months
Primary	The change of visceral fat	The visceral fat (10 cm^2) was assessed by InBody770.	Change from Baseline visceral fat at 2 months
Secondary	The change of fasting glycemia	Venous blood was sampled to measure concentrations of fasting glycemia	Change from Baseline fasting glycemia at 2 months
Secondary	The change of aspartate aminotransferase	Venous blood was sampled to measure concentrations of aspartate aminotransferase	Change from Baseline aspartate aminotransferase at 2 months
Secondary	The change of alanine aminotransferase	Venous blood was sampled to measure concentrations of alanine aminotransferase	Change from Baseline alanine aminotransferase at 2 months
Secondary	The change of albumin	Venous blood was sampled to measure concentrations of albumin	Change from Baseline albumin at 2 months
Secondary	The change of creatinine	Venous blood was sampled to measure concentrations of creatine	Change from Baseline creatinine at 2 months
Secondary	The change of uric acid	Venous blood was sampled to measure concentrations of uric acid	Change from Baseline uric acid at 2 months
Secondary	The change of white blood cell	Venous blood was sampled to measure concentrations of white blood cell	Change from Baseline white blood cell at 2 months