The Effect of Consuming on Body Composition and Blood Biochemistry Index

Study Overview
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Brief Summary
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To assess the effect of consuming on body composition and blood biochemistry index

Official Title
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The Effect of Consuming on Body Composition and Blood Biochemistry Index

Conditions
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Gut Microbiota

Intervention / Treatment
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* Dietary Supplement: Fruit and vegetable solid drink


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: weight loss program kit<br>weight loss program kit | Dietary Supplement: Fruit and vegetable solid drink<br>* weight loss program supplement<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. | Change from Baseline body fat mass at 2 months | 
| The change of Triglyceride | Venous blood was sampled to measure concentrations of Triglyceride | Change from Baseline triglyceride at 2 months | 
| The change of Total cholesterol | Venous blood was sampled to measure concentrations of Total cholestrol | Change from Baseline total cholesterol at 2 months | 
| The change of HDL-cholesterol | Venous blood was sampled to measure concentrations of HDL-cholestrol | Change from Baseline HDL-cholesterol at 2 months | 
| The change of LDL-cholesterol | Venous blood was sampled to measure concentrations of LDL-cholestrol | Change from Baseline LDL-cholesterol at 2 months | 
| Fecal microbiome analysis | Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR. | Change from Baseline Fecal microbiome at 2 months | 
| 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 | 
| The change of body fat percentage | The body fat percentage (%) was assessed by InBody770 | Change from Baseline body fat percentage at 2 months | 
| The change of visceral fat | The visceral fat (10 cm^2) was assessed by InBody770. | Change from Baseline visceral fat at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of fasting glycemia | Venous blood was sampled to measure concentrations of fasting glycemia | Change from Baseline fasting glycemia at 2 months | 
| The change of aspartate aminotransferase | Venous blood was sampled to measure concentrations of aspartate aminotransferase | Change from Baseline aspartate aminotransferase at 2 months | 
| The change of alanine aminotransferase | Venous blood was sampled to measure concentrations of alanine aminotransferase | Change from Baseline alanine aminotransferase at 2 months | 
| The change of albumin | Venous blood was sampled to measure concentrations of albumin | Change from Baseline albumin at 2 months | 
| The change of creatinine | Venous blood was sampled to measure concentrations of creatine | Change from Baseline creatinine at 2 months | 
| The change of uric acid | Venous blood was sampled to measure concentrations of uric acid | Change from Baseline uric acid at 2 months | 
| 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 | 

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