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

Study Overview
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Brief Summary
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To assess the effects of consuming enzymes and prebiotics on improvement of weight loss and biochemical parameters

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

Conditions
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Gut Microbiota

Intervention / Treatment
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* Other: normal diet
* Other: weight loss program kit
* Other: weight loss program kit with A. muciniphila prebiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: normal diet<br> | Other: normal diet<br>* Control<br>|
| Experimental: weight loss program kit<br> | Other: weight loss program kit<br>* 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.<br>|
| Experimental: weight loss program kit with A. muciniphila prebiotics<br> | Other: weight loss program kit with A. muciniphila prebiotics<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of fasting glycemia | Venous blood was sampled to measure concentrations of fasting glycemia | Months 0, 1 and 2 | 
| The change of aspartate aminotransferase | Venous blood was sampled to measure concentrations of aspartate aminotransferase | Months 0, 1 and 2 | 
| The change of alanine aminotransferase | Venous blood was sampled to measure concentrations of alanine aminotransferase | Months 0, 1 and 2 | 
| The change of albumin | Venous blood was sampled to measure concentrations of albumin | Months 0, 1 and 2 | 
| The change of creatine | Venous blood was sampled to measure concentrations of creatine | Months 0, 1 and 2 | 
| The change of uric acid | Venous blood was sampled to measure concentrations of uric acid | Months 0, 1 and 2 | 
| The change of white blood cell | Venous blood was sampled to measure concentrations of white blood cell | Months 0, 1 and 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anthropometric index, Biochemical items