Clinical trial NCT04501601: The Effect of Consuming on Body Composition and Blood Biochemistry Index
Official title: The Effect of Consuming on Body Composition and Blood Biochemistry Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiota
Keywords: Anthropometric index
Biochemical items
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-06
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: The change of body fat mass
timeFrame: Change from Baseline body fat mass at 2 months
measure: The change of Triglyceride
timeFrame: Change from Baseline triglyceride at 2 months
measure: The change of Total cholesterol
timeFrame: Change from Baseline total cholesterol at 2 months
measure: The change of HDL-cholesterol
timeFrame: Change from Baseline HDL-cholesterol at 2 months
measure: The change of LDL-cholesterol
timeFrame: Change from Baseline LDL-cholesterol at 2 months
measure: Fecal microbiome analysis
timeFrame: Change from Baseline Fecal microbiome at 2 months
measure: The change of body mass index (BMI)
timeFrame: Change from Baseline body mass index at 2 months
measure: The change of body fat percentage
timeFrame: Change from Baseline body fat percentage at 2 months
measure: The change of visceral fat
timeFrame: Change from Baseline visceral fat at 2 months
Secondary outcomes:
measure: The change of fasting glycemia
timeFrame: Change from Baseline fasting glycemia at 2 months
measure: The change of aspartate aminotransferase
timeFrame: Change from Baseline aspartate aminotransferase at 2 months
measure: The change of alanine aminotransferase
timeFrame: Change from Baseline alanine aminotransferase at 2 months
measure: The change of albumin
timeFrame: Change from Baseline albumin at 2 months
measure: The change of creatinine
timeFrame: Change from Baseline creatinine at 2 months
measure: The change of uric acid
timeFrame: Change from Baseline uric acid at 2 months
measure: The change of white blood cell
timeFrame: Change from Baseline white blood cell at 2 months
Other outcomes:
Locations:
city: Pingtung
country: Taiwan
facility: National Pingtung University of Science and Technology
state: Neipu Township
Study officials:
affiliation: Study Principal Investigator
name: Bo-Han Wu
role: PRINCIPAL_INVESTIGATOR
References: