The Effect of Consuming on Body Composition and Blood Biochemistry Index

January 13, 2021 updated by: TCI Co., Ltd.
To assess the effect of consuming on body composition and blood biochemistry index

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change of body fat mass
Time Frame: Change from Baseline body fat mass at 2 months
The body fat mass (kg) was assessed by InBody770.
Change from Baseline body fat mass at 2 months
The change of Triglyceride
Time Frame: Change from Baseline triglyceride at 2 months
Venous blood was sampled to measure concentrations of Triglyceride
Change from Baseline triglyceride at 2 months
The change of Total cholesterol
Time Frame: Change from Baseline total cholesterol at 2 months
Venous blood was sampled to measure concentrations of Total cholestrol
Change from Baseline total cholesterol at 2 months
The change of HDL-cholesterol
Time Frame: Change from Baseline HDL-cholesterol at 2 months
Venous blood was sampled to measure concentrations of HDL-cholestrol
Change from Baseline HDL-cholesterol at 2 months
The change of LDL-cholesterol
Time Frame: Change from Baseline LDL-cholesterol at 2 months
Venous blood was sampled to measure concentrations of LDL-cholestrol
Change from Baseline LDL-cholesterol at 2 months
Fecal microbiome analysis
Time Frame: Change from Baseline Fecal microbiome at 2 months
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)
Time Frame: 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.
Change from Baseline body mass index at 2 months
The change of body fat percentage
Time Frame: Change from Baseline body fat percentage at 2 months
The body fat percentage (%) was assessed by InBody770
Change from Baseline body fat percentage at 2 months
The change of visceral fat
Time Frame: Change from Baseline visceral fat at 2 months
The visceral fat (10 cm^2) was assessed by InBody770.
Change from Baseline visceral fat at 2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change of fasting glycemia
Time Frame: Change from Baseline fasting glycemia at 2 months
Venous blood was sampled to measure concentrations of fasting glycemia
Change from Baseline fasting glycemia at 2 months
The change of aspartate aminotransferase
Time Frame: Change from Baseline aspartate aminotransferase at 2 months
Venous blood was sampled to measure concentrations of aspartate aminotransferase
Change from Baseline aspartate aminotransferase at 2 months
The change of alanine aminotransferase
Time Frame: Change from Baseline alanine aminotransferase at 2 months
Venous blood was sampled to measure concentrations of alanine aminotransferase
Change from Baseline alanine aminotransferase at 2 months
The change of albumin
Time Frame: Change from Baseline albumin at 2 months
Venous blood was sampled to measure concentrations of albumin
Change from Baseline albumin at 2 months
The change of creatinine
Time Frame: Change from Baseline creatinine at 2 months
Venous blood was sampled to measure concentrations of creatine
Change from Baseline creatinine at 2 months
The change of uric acid
Time Frame: Change from Baseline uric acid at 2 months
Venous blood was sampled to measure concentrations of uric acid
Change from Baseline uric acid at 2 months
The change of white blood cell
Time Frame: Change from Baseline white blood cell at 2 months
Venous blood was sampled to measure concentrations of white blood cell
Change from Baseline white blood cell at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TCI Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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