Gut MicrobiotaNCT04303481
The Effect of Consuming Enzymes and Prebiotics on Body Composition and Blood Biochemical Index
A study testing normal diet, weight loss program kit and weight loss program kit with A. muciniphila prebiotics in people with Gut Microbiota, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess the effects of consuming enzymes and prebiotics on improvement of weight loss and biochemical parameters Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- What is being tested?
- normal diet, weight loss program kit and weight loss program kit with A. muciniphila prebiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Aug 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged between 20 and 50 years old
- Body mass index (BMI) ≥ 22 (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.
Who cannot join
- Pregnant or breastfeeding woman
- Menopausal woman
- Diabetes mellitus
- Implementation in weight loss programs before a half year of this study
- Metabolic disorders
- Kidney diseases
Show all 11Show fewer
- Liver diseases
- Cardiovascular diseases
- Nervous system diseases
- Gastrointestinal diseases
- Heavy drinking or constant drug use.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Pingtung University of Science and Technology
Pingtung City, Neipu Township, 91201
About this study
To assess the effects of consuming enzymes and prebiotics on improvement of weight loss and biochemical parameters
- Conditions
- Gut Microbiota
- Being tested
- normal diet, weight loss program kit, weight loss program kit with A. muciniphila prebiotics
- Keywords
- Anthropometric index, Biochemical items
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal dietOther
Control
weight loss program kitOther
Subjects should adhere to the eating plan, which contained the following kit components : four flavors of collagen drinks [i.e., Caviar Collagen Enzyme Drink, Collagen Enzyme Drinks (Peach Taste), Collagen Enzyme Drinks (Grape Fruit Taste), Saussurea involucrata Enzyme Drink (Litchi Taste)], six flavors of mike shakes (i.e., Corn Soup Mike Shake, Strawberry Mike Shake, Chocolate Mike Shake, Vanilla Mike Shake, Banana Mike Shakes, Matcha Mike Shakes), Fruit and Vegitable Congee, and Botanical Liquid Sachet.
weight loss program kit with A. muciniphila prebioticsOther
Subjects should adhere to the eating plan, which contained the following kit components : four flavors of collagen drinks [i.e., Caviar Collagen Enzyme Drink, Collagen Enzyme Drinks (Peach Taste), Collagen Enzyme Drinks (Grape Fruit Taste), Saussurea involucrata Enzyme Drink (Litchi Taste)], six flavors of mike shakes (i.e., Corn Soup Mike Shake, Strawberry Mike Shake, Chocolate Mike Shake, Vanilla Mike Shake, Banana Mike Shakes, Matcha Mike Shakes), Fruit and Vegitable Congee, Botanical Liquid Sachet, and Probiotics Liquid Sachet
| Study group | Role | What they receive |
|---|---|---|
| normal diet | Other | Not described Receives: Other: normal diet |
| weight loss program kit | Experimental | Not described Receives: Other: weight loss program kit |
| weight loss program kit with A. muciniphila prebiotics | Experimental | Not described Receives: Other: weight loss program kit with A. muciniphila prebiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of body fat mass
The body fat mass (kg) was assessed by InBody770.
Measured: Months 0, 1 and 2
The change of Triglyceride
Venous blood was sampled to measure concentrations of Triglyceride
Measured: Months 0, 1 and 2
The change of Total cholestrol
Venous blood was sampled to measure concentrations of Total cholestrol
Measured: Months 0, 1 and 2
The change of HDL-cholestrol
Venous blood was sampled to measure concentrations of HDL-cholestrol
Measured: Months 0, 1 and 2
The change of LDL-cholestrol
Venous blood was sampled to measure concentrations of LDL-cholestrol
Measured: Months 0, 1 and 2
Fecal microbiome analysis
Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.
Measured: Months 0, 1 and 2
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.
Measured: Months 0, 1 and 2
The change of body fat percentage
The body fat percentage (%) was assessed by InBody770.
Measured: Months 0, 1 and 2
The change of visceral fat
The visceral fat (10 cm^2) was assessed by InBody770.
Measured: Months 0, 1 and 2
Secondary outcomes (7)
The change of fasting glycemia
Venous blood was sampled to measure concentrations of fasting glycemia
Measured: Months 0, 1 and 2
The change of aspartate aminotransferase
Venous blood was sampled to measure concentrations of aspartate aminotransferase
Measured: Months 0, 1 and 2
The change of alanine aminotransferase
Venous blood was sampled to measure concentrations of alanine aminotransferase
Measured: Months 0, 1 and 2
The change of albumin
Venous blood was sampled to measure concentrations of albumin
Measured: Months 0, 1 and 2
The change of creatine
Venous blood was sampled to measure concentrations of creatine
Measured: Months 0, 1 and 2
The change of uric acid
Venous blood was sampled to measure concentrations of uric acid
Measured: Months 0, 1 and 2
The change of white blood cell
Venous blood was sampled to measure concentrations of white blood cell
Measured: Months 0, 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start10 Aug 2019
- Primary completion3 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bo-Han Wu, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303481
- Sponsor's protocol ID
- 19-062-A
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Consuming Enzymes and Prebiotics on Body Composition and Blood Biochemical Index
- ClinicalTrials.gov ID
- NCT04303481
- Acronym / sponsor ID
- 19-062-A
- Conditions
- Gut Microbiota
- Keywords
- Anthropometric index, Biochemical items
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 3 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effects of consuming enzymes and prebiotics on improvement of weight loss and biochemical parameters
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal diet | Other | Other: normal diet |
| weight loss program kit | Experimental | Other: weight loss program kit |
| weight loss program kit with A. muciniphila prebiotics | Experimental | Other: weight loss program kit with A. muciniphila prebiotics |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female aged between 20 and 50 years old
- Body mass index (BMI) ≥ 22 (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.
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding woman
- Menopausal woman
- Diabetes mellitus
- Implementation in weight loss programs before a half year of this study
- Metabolic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal dietControl | Other | normal diet |
| weight loss program kitSubjects should adhere to the eating plan, which contained the following kit components : four flavors of collagen drinks [i.e., Caviar Collagen Enzyme Drink, Collagen Enzyme Drinks (Peach Taste), Collagen Enzyme Drinks (Grape Fruit Taste), Saussurea involucrata Enzyme Drink (Litchi Taste)], six flavors of mike shakes (i.e., Corn Soup Mike Shake, Strawberry Mike Shake, Chocolate Mike Shake, Vanilla Mike Shake, Banana Mike Shakes, Matcha Mike Shakes), Fruit and Vegitable Congee, and Botanical Liquid Sachet. | Other | weight loss program kit |
| weight loss program kit with A. muciniphila prebioticsSubjects should adhere to the eating plan, which contained the following kit components : four flavors of collagen drinks [i.e., Caviar Collagen Enzyme Drink, Collagen Enzyme Drinks (Peach Taste), Collagen Enzyme Drinks (Grape Fruit Taste), Saussurea involucrata Enzyme Drink (Litchi Taste)], six flavors of mike shakes (i.e., Corn Soup Mike Shake, Strawberry Mike Shake, Chocolate Mike Shake, Vanilla Mike Shake, Banana Mike Shakes, Matcha Mike Shakes), Fruit and Vegitable Congee, Botanical Liquid Sachet, and Probiotics Liquid Sachet | Other | weight loss program kit with A. muciniphila prebiotics |
Primary outcome
The change of body fat mass
Time frame: Months 0, 1 and 2
The body fat mass (kg) was assessed by InBody770.
The change of Triglyceride
Time frame: Months 0, 1 and 2
Venous blood was sampled to measure concentrations of Triglyceride
The change of Total cholestrol
Time frame: Months 0, 1 and 2
Venous blood was sampled to measure concentrations of Total cholestrol
The change of HDL-cholestrol
Time frame: Months 0, 1 and 2
Venous blood was sampled to measure concentrations of HDL-cholestrol
The change of LDL-cholestrol
Time frame: Months 0, 1 and 2
Venous blood was sampled to measure concentrations of LDL-cholestrol
Fecal microbiome analysis
Time frame: Months 0, 1 and 2
Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.
The change of body mass index (BMI)
Time frame: Months 0, 1 and 2
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 body fat percentage
Time frame: Months 0, 1 and 2
The body fat percentage (%) was assessed by InBody770.
The change of visceral fat
Time frame: Months 0, 1 and 2
The visceral fat (10 cm^2) was assessed by InBody770.
7 secondary outcomes
The change of fasting glycemia
Time frame: Months 0, 1 and 2
The change of aspartate aminotransferase
Time frame: Months 0, 1 and 2
The change of alanine aminotransferase
Time frame: Months 0, 1 and 2
The change of albumin
Time frame: Months 0, 1 and 2
The change of creatine
Time frame: Months 0, 1 and 2
The change of uric acid
Time frame: Months 0, 1 and 2
The change of white blood cell
Time frame: Months 0, 1 and 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo-Han Wu principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal diet, weight loss program kit and weight loss program kit with A. muciniphila prebiotics in people with Gut Microbiota, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of body fat mass (time frame: Months 0, 1 and 2). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.