Over Weight PeopleNCT04651023
Shanghai Meiji Health Science and Technology Co., Ltd
A study testing Nelumbo nucifera Leaf Extract in people with Over Weight People, run by Shanghai Meiji Health Science and Technology Co., Ltd..
Trial summary
Investigators performed a randomized double-blind trial to determine the effects of long-term NnEx ingestion in patients with overweight or obesity. Ninety-five participants (23<BMI<30 kg/m2) were randomly allocated to three groups: a control group, a 1 g/day NnEx group, and a 2 g/day NnEx group. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Over Weight People
- What is being tested?
- Nelumbo nucifera Leaf Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2009to 20 Jun 2009
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has a body mass index (BMI) of 23-30 kg/m2
- Has no history of using any antidiabetic medication
- Absence of liver, kidney, or heart disease
- Absence of food allergy and daily tea consumption <2 L
- Meet all of the above criteria and to follow the instructions given during the study.
Who cannot join
- Testing delayed for >1 week without justification
- Difficulty attending the hospital on the required days
- Lack of data regarding the times of beverage consumption for over 5% of the study
- Abnormal overeating
- Test results believed to be unreliable because of the lack of provision of diet and exercise reports during the fasting period
- Difficulty drawing blood
- Poor confidence in the test data
About this study
Investigators performed a randomized double-blind trial to determine the effects of long-term NnEx ingestion in patients with overweight or obesity. Ninety-five participants (23<BMI<30 kg/m2) were randomly allocated to three groups: a control group, a 1 g/day NnEx group, and a 2 g/day NnEx group. The effects of the consumption of 2 g/day or 1 g/day NnEx for 12 weeks on indices of adiposity and fasting blood metabolic parameters were compared with those of no consumption of NnEx.
- Conditions
- Over Weight People
- Being tested
- Nelumbo nucifera Leaf Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelumbo nucifera Leaf ExtractDietary supplement
Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | During the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (0g NnEx) per day with or after meals. Receives: Dietary Supplement: Nelumbo nucifera Leaf Extract |
| low concentration of NnEx group | Experimental | During the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (1g NnEx) per day with or after meals. Receives: Dietary Supplement: Nelumbo nucifera Leaf Extract |
| high concentration of NnEx group | Experimental | During the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (2g NnEx) per day with or after meals. Receives: Dietary Supplement: Nelumbo nucifera Leaf Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in anthropometrix indices during the study
weight in kilograms
Measured: baseline, 6 weeks, 12 weeks
Changes in anthropometrix indices during the study
height in meters
Measured: baseline, 6 weeks, 12 weeks
Changes in anthropometrix indices during the study
body fat in percentage
Measured: baseline, 6 weeks, 12 weeks
Changes in anthropometrix indices during the study
visceral fat in percentage
Measured: baseline, 6 weeks, 12 weeks
Changes in anthropometrix indices during the study
waist in centimeters
Measured: baseline, 6 weeks, 12 weeks
Changes in anthropometrix indices during the study
hip in centimeters
Measured: baseline, 6 weeks, 12 weeks
Secondary outcomes (9)
Changes in fasting biochemical indices during the study
glucose in mmol/L
Measured: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
HbA1c in mmol/L
Measured: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
TG in mmol/L
Measured: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
FFA in mmol/L
Measured: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
T-cho in mmol/L
Measured: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
HDL-cho in mmol/L
Measured: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
LDL-cho in mmol/L
Measured: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
ASP in mmol/L
Measured: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
BUN in mmol/L
Measured: baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start10 Jan 2009
- Primary completion15 May 2009
- Study completion20 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Over Weight PeopleStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Meiji Health Science and Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Zai-Si Ji, phD, Shanghai Meiji Health Science and Technology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651023
- Sponsor's protocol ID
- ShanghaiMHST
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Meiji Health Science and Technology Co., Ltd
- ClinicalTrials.gov ID
- NCT04651023
- Acronym / sponsor ID
- ShanghaiMHST
- Conditions
- Over Weight People
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Shanghai Meiji Health Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2009 (actual)
- Primary completion
- 15 May 2009 (actual)
- Study completion
- 20 Jun 2009 (actual)
- First posted
- 3 Dec 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.
Investigators performed a randomized double-blind trial to determine the effects of long-term NnEx ingestion in patients with overweight or obesity. Ninety-five participants (23<BMI<30 kg/m2) were randomly allocated to three groups: a control group, a 1 g/day NnEx group, and a 2 g/day NnEx group. The effects of the consumption of 2 g/day or 1 g/day NnEx for 12 weeks on indices of adiposity and fasting blood metabolic parameters were compared with those of no consumption of NnEx.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Dietary Supplement: Nelumbo nucifera Leaf ExtractDuring the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (0g NnEx) per day with or after meals. |
| low concentration of NnEx group | Experimental | Dietary Supplement: Nelumbo nucifera Leaf ExtractDuring the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (1g NnEx) per day with or after meals. |
| high concentration of NnEx group | Experimental | Dietary Supplement: Nelumbo nucifera Leaf ExtractDuring the 12-week study period, the participants consumed two bottles (2 *200 mL) of the experimental beverage (2g NnEx) per day with or after meals. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Has a body mass index (BMI) of 23-30 kg/m2
- Has no history of using any antidiabetic medication
- Absence of liver, kidney, or heart disease
- Absence of food allergy and daily tea consumption <2 L
- Meet all of the above criteria and to follow the instructions given during the study.
Key exclusion criteria (7 listed)
- Testing delayed for >1 week without justification
- Difficulty attending the hospital on the required days
- Lack of data regarding the times of beverage consumption for over 5% of the study
- Abnormal overeating
- Test results believed to be unreliable because of the lack of provision of diet and exercise reports during the fasting period
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 |
|---|---|---|
| Nelumbo nucifera Leaf ExtractHot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide. | Dietary supplement | control group, high concentration of NnEx group, low concentration of NnEx group |
Primary outcome
Changes in anthropometrix indices during the study
Time frame: baseline, 6 weeks, 12 weeks
weight in kilograms
Changes in anthropometrix indices during the study
Time frame: baseline, 6 weeks, 12 weeks
height in meters
Changes in anthropometrix indices during the study
Time frame: baseline, 6 weeks, 12 weeks
body fat in percentage
Changes in anthropometrix indices during the study
Time frame: baseline, 6 weeks, 12 weeks
visceral fat in percentage
Changes in anthropometrix indices during the study
Time frame: baseline, 6 weeks, 12 weeks
waist in centimeters
Changes in anthropometrix indices during the study
Time frame: baseline, 6 weeks, 12 weeks
hip in centimeters
9 secondary outcomes
Changes in fasting biochemical indices during the study
Time frame: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
Time frame: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
Time frame: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
Time frame: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
Time frame: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
Time frame: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
Time frame: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
Time frame: baseline, 6 weeks, 12 weeks
Changes in fasting biochemical indices during the study
Time frame: baseline, 6 weeks, 12 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 3 Dec 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nelumbo nucifera Leaf Extract in people with Over Weight People, run by Shanghai Meiji Health Science and Technology Co., Ltd..
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 5 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 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in anthropometrix indices during the study (time frame: baseline, 6 weeks, 12 weeks). The study lists 6 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 3 Dec 2020.