The Effect of Consuming on Body Composition and Blood Biochemistry Index
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TCI Co., Ltd.
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- The change of body fat mass
Study Overview
Brief Summary
To assess the effect of consuming on body composition and blood biochemistry index
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
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)