The Effect of Consuming Enzymes and Prebiotics on Body Composition and Blood Biochemical Index
- Conditions
- Gut Microbiota
- Interventions
- Other: normal dietOther: weight loss program kitOther: weight loss program kit with A. muciniphila prebiotics
- Registration Number
- NCT04303481
- Lead Sponsor
- TCI Co., Ltd.
- Brief Summary
To assess the effects of consuming enzymes and prebiotics on improvement of weight loss and biochemical parameters
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description normal diet normal diet - weight loss program kit weight loss program kit - weight loss program kit with A. muciniphila prebiotics weight loss program kit with A. muciniphila prebiotics -
- Primary Outcome Measures
Name Time Method The change of HDL-cholestrol Months 0, 1 and 2 Venous blood was sampled to measure concentrations of HDL-cholestrol
The change of LDL-cholestrol Months 0, 1 and 2 Venous blood was sampled to measure concentrations of LDL-cholestrol
The change of visceral fat Months 0, 1 and 2 The visceral fat (10 cm\^2) was assessed by InBody770.
The change of body fat mass Months 0, 1 and 2 The body fat mass (kg) was assessed by InBody770.
The change of Triglyceride Months 0, 1 and 2 Venous blood was sampled to measure concentrations of Triglyceride
Fecal microbiome analysis Months 0, 1 and 2 Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.
The change of body fat percentage Months 0, 1 and 2 The body fat percentage (%) was assessed by InBody770.
The change of Total cholestrol Months 0, 1 and 2 Venous blood was sampled to measure concentrations of Total cholestrol
The change of body mass index (BMI) Months 0, 1 and 2 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.
- Secondary Outcome Measures
Name Time Method The change of uric acid Months 0, 1 and 2 Venous blood was sampled to measure concentrations of uric acid
The change of alanine aminotransferase Months 0, 1 and 2 Venous blood was sampled to measure concentrations of alanine aminotransferase
The change of white blood cell Months 0, 1 and 2 Venous blood was sampled to measure concentrations of white blood cell
The change of creatine Months 0, 1 and 2 Venous blood was sampled to measure concentrations of creatine
The change of fasting glycemia Months 0, 1 and 2 Venous blood was sampled to measure concentrations of fasting glycemia
The change of aspartate aminotransferase Months 0, 1 and 2 Venous blood was sampled to measure concentrations of aspartate aminotransferase
The change of albumin Months 0, 1 and 2 Venous blood was sampled to measure concentrations of albumin
Trial Locations
- Locations (1)
National Pingtung University of Science and Technology
🇨🇳Pingtung, Neipu Township, Taiwan