The Effect of Consuming on Body Composition and Blood Biochemistry Index

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

Study Overview

• Status: Completed
• Conditions: Gut Microbiota
• Intervention / Treatment: Dietary supplement: Fruit and vegetable solid drink

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Neipu Township
    • Pingtung, Neipu Township, Taiwan, 91201
      • National Pingtung University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental: weight loss program kit; weight loss program kit	Dietary supplement: Fruit and vegetable solid drink; weight loss program supplement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: August 2, 2020
• First Posted (ACTUAL): August 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Anthropometric index; Biochemical items
• Other Study ID Numbers: 20-039-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No