MedPath

The Effect of Consuming on Body Composition and Blood Biochemistry Index

Not Applicable
Completed
Conditions
Gut Microbiota
Interventions
Dietary Supplement: Fruit and vegetable solid drink
Registration Number
NCT04501601
Lead Sponsor
TCI Co., Ltd.
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
25
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Experimental: weight loss program kitFruit and vegetable solid drinkweight loss program kit
Primary Outcome Measures
NameTimeMethod
The change of body fat massChange from Baseline body fat mass at 2 months

The body fat mass (kg) was assessed by InBody770.

The change of TriglycerideChange from Baseline triglyceride at 2 months

Venous blood was sampled to measure concentrations of Triglyceride

The change of LDL-cholesterolChange from Baseline LDL-cholesterol at 2 months

Venous blood was sampled to measure concentrations of LDL-cholestrol

The change of HDL-cholesterolChange from Baseline HDL-cholesterol at 2 months

Venous blood was sampled to measure concentrations of HDL-cholestrol

Fecal microbiome analysisChange 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)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 fatChange from Baseline visceral fat at 2 months

The visceral fat (10 cm\^2) was assessed by InBody770.

The change of Total cholesterolChange from Baseline total cholesterol at 2 months

Venous blood was sampled to measure concentrations of Total cholestrol

The change of body fat percentageChange from Baseline body fat percentage at 2 months

The body fat percentage (%) was assessed by InBody770

Secondary Outcome Measures
NameTimeMethod
The change of white blood cellChange from Baseline white blood cell at 2 months

Venous blood was sampled to measure concentrations of white blood cell

The change of fasting glycemiaChange from Baseline fasting glycemia at 2 months

Venous blood was sampled to measure concentrations of fasting glycemia

The change of albuminChange from Baseline albumin at 2 months

Venous blood was sampled to measure concentrations of albumin

The change of aspartate aminotransferaseChange from Baseline aspartate aminotransferase at 2 months

Venous blood was sampled to measure concentrations of aspartate aminotransferase

The change of uric acidChange from Baseline uric acid at 2 months

Venous blood was sampled to measure concentrations of uric acid

The change of alanine aminotransferaseChange from Baseline alanine aminotransferase at 2 months

Venous blood was sampled to measure concentrations of alanine aminotransferase

The change of creatinineChange from Baseline creatinine at 2 months

Venous blood was sampled to measure concentrations of creatine

Trial Locations

Locations (1)

National Pingtung University of Science and Technology

🇨🇳

Pingtung, Neipu Township, Taiwan

© Copyright 2025. All Rights Reserved by MedPath