GastroenterologyNCT04692792
Efficacy Evaluation of Dai Dai Flower on Body Weight
A study testing Dai Dai flower drink in people with Gastroenterology, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess the Dai Dai flower extract on body weight control Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroenterology
- What is being tested?
- Dai Dai flower drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jan 2021to 15 Jun 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female aged between 20 and 60 years old
- Body mass index (BMI) ≥ 24 (kg/m^2) or body fat mass ≥ 25%
Who cannot join
- Pregnant or breastfeeding woman
- Implementation in weight loss programs, consumption drugs or supplements for weight control before 3 months of this study
- Participate weight control or fat loss human studies before 3 months of this study
- History of cardiovascular disease, liver disease, kidney disease, endocrine disease, or other major organic diseases (according to subjects reporting).
- Person who has received major surgery or bariatric surgery (according to medical history).
- Person who has received constant drug use.
- People with mental illness
Trial locations and contacts
1 site in 1 country.
About this study
To assess the Dai Dai flower extract on body weight control
- Conditions
- Gastroenterology
- Being tested
- Placebo drink, Dai Dai flower drink
- Keywords
- Obesity, Weight control, Dai Dai flower
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo drinkDietary supplement
consume 1 bottle (50 mL) per day for 8 weeks
Dai Dai flower drinkDietary supplement
consume 1 bottle (50 mL) per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: Placebo drink |
| Dai Dai flower drink | Experimental | Not described Receives: Dietary Supplement: Dai Dai flower drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of body weight
The body weight (kg) was assessed by InBody.
Measured: Change from Baseline body weight at 8 weeks
The change of BMI
The BMI was assessed by InBody.
Measured: Change from Baseline BMI at 8 weeks
Secondary outcomes (19)
The change of body fat mass
The body fat mass (kg) was assessed by InBody.
Measured: Change from Baseline body fat mass at 8 weeks
The change of visceral fat mass
The visceral fat mass (kg) was assessed by InBody.
Measured: Change from Baseline visceral fat mass at 8 weeks
The change of waist-hip ratio
The waist-hip ratio was assessed by measuring tape.
Measured: Change from Baseline waist-hip ratio at 8 weeks
The change of basal metabolic rate
The basal metabolic rate was assessed by InBody.
Measured: Change from Baseline basal metabolic rate at 8 weeks
The change of AST
Venous blood was sampled to measure concentrations of aspartate transaminase (AST)
Measured: Change from Baseline AST at 8 weeks
The change of ALT
Venous blood was sampled to measure concentrations of alanine aminotransferase (ALT)
Measured: Change from Baseline ALT at 8 weeks
The change of Creatinine
Venous blood was sampled to measure concentrations of creatinine
Measured: Change from Baseline creatinine at 8 weeks
The change of BUN
Venous blood was sampled to measure concentrations of blood urea nitrogen (BUN)
Measured: Change from Baseline BUN at 8 weeks
The change of fasting glycemia
Venous blood was sampled to measure concentrations of fasting glycemia
Measured: Change from Baseline fasting glycemia at 8 weeks
The change of total cholesterol
Venous blood was sampled to measure concentrations of total cholesterol
Measured: Change from Baseline total cholesterol at 8 weeks
The change of triglyceride
Venous blood was sampled to measure concentrations of triglyceride
Measured: Change from Baseline triglyceride at 8 weeks
The change of HDL-cholesterol
Venous blood was sampled to measure concentrations of HDL-cholesterol
Measured: Change from Baseline HDL-cholesterol at 8 weeks
The change of LDL-cholesterol
Venous blood was sampled to measure concentrations of LDL-cholesterol
Measured: Change from Baseline LDL-cholesterol at 8 weeks
The change of insulin
Venous blood was sampled to measure concentrations of insulin
Measured: Change from Baseline insulin at 8 weeks
The change of adiponectin
Venous blood was sampled to measure concentrations of adiponectin
Measured: Change from Baseline adiponectin at 8 weeks
The change of leptin
Venous blood was sampled to measure concentrations of leptin
Measured: Change from Baseline leptin at 8 weeks
The change of IFN-γ
Venous blood was sampled to measure concentrations of IFN-γ
Measured: Change from Baseline IFN-γ at 8 weeks
The change of IL-2
Venous blood was sampled to measure concentrations of IL-2
Measured: Change from Baseline IL-2 at 8 weeks
The change of IL-1beta
Venous blood was sampled to measure concentrations of IL-1beta
Measured: Change from Baseline IL-1beta at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start4 Jan 2021
- Primary completion6 Mar 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenterologyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hsiu-Mei Chiang, Prof., Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692792
- Sponsor's protocol ID
- CMUH109-REC1-161
- Status last verified
- Aug 2021
- First submitted
- 29 Dec 2020
- Last updated
- 4 Aug 2021
- 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 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Dai Dai Flower on Body Weight
- ClinicalTrials.gov ID
- NCT04692792
- Acronym / sponsor ID
- CMUH109-REC1-161
- Conditions
- Gastroenterology
- Keywords
- Obesity, Weight control, Dai Dai flower
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 6 Mar 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 5 Jan 2021 (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 Dai Dai flower extract on body weight control
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo drink |
| Dai Dai flower drink | Experimental | Dietary Supplement: Dai Dai flower drink |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male or female aged between 20 and 60 years old
- Body mass index (BMI) ≥ 24 (kg/m^2) or body fat mass ≥ 25%
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding woman
- Implementation in weight loss programs, consumption drugs or supplements for weight control before 3 months of this study
- Participate weight control or fat loss human studies before 3 months of this study
- History of cardiovascular disease, liver disease, kidney disease, endocrine disease, or other major organic diseases (according to subjects reporting).
- Person who has received major surgery or bariatric surgery (according to medical history).
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 |
|---|---|---|
| Placebo drinkconsume 1 bottle (50 mL) per day for 8 weeks | Dietary supplement | Placebo drink |
| Dai Dai flower drinkconsume 1 bottle (50 mL) per day for 8 weeks | Dietary supplement | Dai Dai flower drink |
Primary outcome
The change of body weight
Time frame: Change from Baseline body weight at 8 weeks
The body weight (kg) was assessed by InBody.
The change of BMI
Time frame: Change from Baseline BMI at 8 weeks
The BMI was assessed by InBody.
19 secondary outcomes
The change of body fat mass
Time frame: Change from Baseline body fat mass at 8 weeks
The change of visceral fat mass
Time frame: Change from Baseline visceral fat mass at 8 weeks
The change of waist-hip ratio
Time frame: Change from Baseline waist-hip ratio at 8 weeks
The change of basal metabolic rate
Time frame: Change from Baseline basal metabolic rate at 8 weeks
The change of AST
Time frame: Change from Baseline AST at 8 weeks
The change of ALT
Time frame: Change from Baseline ALT at 8 weeks
The change of Creatinine
Time frame: Change from Baseline creatinine at 8 weeks
The change of BUN
Time frame: Change from Baseline BUN at 8 weeks
The change of fasting glycemia
Time frame: Change from Baseline fasting glycemia at 8 weeks
The change of total cholesterol
Time frame: Change from Baseline total cholesterol at 8 weeks
The change of triglyceride
Time frame: Change from Baseline triglyceride at 8 weeks
The change of HDL-cholesterol
Time frame: Change from Baseline HDL-cholesterol at 8 weeks
The change of LDL-cholesterol
Time frame: Change from Baseline LDL-cholesterol at 8 weeks
The change of insulin
Time frame: Change from Baseline insulin at 8 weeks
The change of adiponectin
Time frame: Change from Baseline adiponectin at 8 weeks
The change of leptin
Time frame: Change from Baseline leptin at 8 weeks
The change of IFN-γ
Time frame: Change from Baseline IFN-γ at 8 weeks
The change of IL-2
Time frame: Change from Baseline IL-2 at 8 weeks
The change of IL-1beta
Time frame: Change from Baseline IL-1beta at 8 weeks
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 4 Aug 2021.
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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.
Hsiu-Mei Chiang, Prof. principal investigator
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dai Dai flower drink in people with Gastroenterology, 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 2 inclusion and 7 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 4 Aug 2021. 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. Some participants in this study may receive a placebo. 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 weight (time frame: Change from Baseline body weight at 8 weeks). The study lists 2 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 4 Aug 2021.