DiabetesNCT05738655
Effectiveness of Pumpkin Seed Extract on Improving Blood Sugar Level in Subhealth Subjects
A study testing Pumpkin seed extract (Low dose) and Pumpkin seed extract (High dose) in people with Diabetes and Metabolic Disease, run by Greenyn Biotechnology Co., Ltd. at 1 site in Taiwan.
Trial summary
This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract on blood sugar management in subhealth people. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Metabolic Disease
- What is being tested?
- Pumpkin seed extract (Low dose) and Pumpkin seed extract (High dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2023to 31 Oct 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting blood sugar levels from 100 to 125 mg/dL
- Glycated hemoglobin levels from 5.7 to 6.4%
- 2-hour OGTT levels from 140 to 199 mg/dL
Who cannot join
- Pregnant women or preparing for pregnancy.
- Lactating women.
- Women gave birth 6 months before the study.
- Poor kindy funciton
- Severe cardiovascular or other chronic diseases
- Patients with type I or II diabetes
Show all 11Show fewer
- Poor compliance
- Alcohol abuser
- Using anti-diabetic or weight managent supplements
- Blood transfusion three months before the study
- Pumpkin seed allergy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
WanFang Hospital
Taipei, 116
Ming-Shun Wu, MD, +886-229307930, mswu@tmu.edu.tw
Ming-Shun Wu, MD
About this study
This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract on blood sugar management in subhealth people.
- Conditions
- Diabetes, Metabolic Disease
- Being tested
- Pumpkin seed extract (Low dose), Pumpkin seed extract (High dose), Placebo
- Medical subject headings
- Diabetes Mellitus, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pumpkin seed extract (Low dose)Dietary supplement
Pumpkin seed extract standardized with specific peptides (300 mg/day)
Pumpkin seed extract (High dose)Dietary supplement
Pumpkin seed extract standardized with specific peptides (600 mg/day)
PlaceboDietary supplement
Placeo (300 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Placebo capsule, one capsule/day (300 mg/day) for 3 months Receives: Dietary Supplement: Placebo |
| Low dose | Experimental | Pumpkin seed extract capsule, one capsule/day (300 mg/day) for 3 months Receives: Dietary Supplement: Pumpkin seed extract (Low dose) |
| High dose | Experimental | Pumpkin seed extract capsule, two capsules/day (600 mg/day) for 3 months Receives: Dietary Supplement: Pumpkin seed extract (High dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical analysis
Changes in fasting blodd sugar levels of 60 pariticpants will be analyzed between baseline and week 12.
Measured: Baseline up to 12 weeks
Biochemical analysis
Changes in glycosylated hemoglobin levels of 60 pariticpants will be analyzed between baseline and week 12.
Measured: Baseline up to 12 weeks
Biochemical analysis
Changes in insulin levels of 60 pariticpants will be analyzed between baseline and week 12.
Measured: Baseline up to 12 weeks
Biochemical analysis
Changes in incremental area under the curve for glucose for 60 pariticpants will be analyzed between baseline and week 12.
Measured: Baseline up to 12 weeks
Hormone analysis
Changes in GLP-1 levels of 60 pariticpants will be analyzed between baseline and week 12.
Measured: Baseline up to 12 weeks
Hormone analysis
Changes in DPP4 levels of 60 pariticpants will be analyzed between baseline and week 12.
Measured: Baseline up to 12 weeks
Hormone analysis
Changes in adiponectin levels of 60 pariticpants will be analyzed between baseline and week 12.
Measured: Baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Mar 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Greenyn Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University
- Responsible party
- Sponsor
- Investigators
- Ming-Shun Wu, MD, Principal investigator, WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738655
- Sponsor's protocol ID
- A-111-110
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2023
- Last updated
- 23 Feb 2024
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pumpkin Seed Extract on Improving Blood Sugar Level in Subhealth Subjects
- ClinicalTrials.gov ID
- NCT05738655
- Acronym / sponsor ID
- A-111-110
- Conditions
- Diabetes, Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Greenyn Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 22 Feb 2023 (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.
This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract on blood sugar management in subhealth people.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule, one capsule/day (300 mg/day) for 3 months |
| Low dose | Experimental | Dietary Supplement: Pumpkin seed extract (Low dose)Pumpkin seed extract capsule, one capsule/day (300 mg/day) for 3 months |
| High dose | Experimental | Dietary Supplement: Pumpkin seed extract (High dose)Pumpkin seed extract capsule, two capsules/day (600 mg/day) for 3 months |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fasting blood sugar levels from 100 to 125 mg/dL
- Glycated hemoglobin levels from 5.7 to 6.4%
- 2-hour OGTT levels from 140 to 199 mg/dL
Key exclusion criteria (11 listed)
- Pregnant women or preparing for pregnancy.
- Lactating women.
- Women gave birth 6 months before the study.
- Poor kindy funciton
- Severe cardiovascular or other chronic diseases
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 |
|---|---|---|
| Pumpkin seed extract (Low dose)Pumpkin seed extract standardized with specific peptides (300 mg/day) | Dietary supplement | Low dose |
| Pumpkin seed extract (High dose)Pumpkin seed extract standardized with specific peptides (600 mg/day) | Dietary supplement | High dose |
| PlaceboPlaceo (300 mg/day) | Dietary supplement | Placebo group |
Primary outcome
Biochemical analysis
Time frame: Baseline up to 12 weeks
Changes in fasting blodd sugar levels of 60 pariticpants will be analyzed between baseline and week 12.
Biochemical analysis
Time frame: Baseline up to 12 weeks
Changes in glycosylated hemoglobin levels of 60 pariticpants will be analyzed between baseline and week 12.
Biochemical analysis
Time frame: Baseline up to 12 weeks
Changes in insulin levels of 60 pariticpants will be analyzed between baseline and week 12.
Biochemical analysis
Time frame: Baseline up to 12 weeks
Changes in incremental area under the curve for glucose for 60 pariticpants will be analyzed between baseline and week 12.
Hormone analysis
Time frame: Baseline up to 12 weeks
Changes in GLP-1 levels of 60 pariticpants will be analyzed between baseline and week 12.
Hormone analysis
Time frame: Baseline up to 12 weeks
Changes in DPP4 levels of 60 pariticpants will be analyzed between baseline and week 12.
Hormone analysis
Time frame: Baseline up to 12 weeks
Changes in adiponectin levels of 60 pariticpants will be analyzed between baseline and week 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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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.
Ming-Shun Wu, MD principal investigator
WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pumpkin seed extract (Low dose) and Pumpkin seed extract (High dose) in people with Diabetes and Metabolic Disease, run by Greenyn Biotechnology 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 3 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Shun Wu, MD (+886-229307930, mswu@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical analysis (time frame: Baseline up to 12 weeks). The study lists 7 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 23 Feb 2024.