PrediabetesNCT06897462
Effect of Science Research Wellness Ndo1 on Glycaemia in Adults With Pre-diabetes
A study testing SRW Ndo1 in people with Prediabetes, run by Wellizen Australia at 1 site in China.
Trial summary
The objective of this study is to test the effect of 12 weeks of supplementation SRW Ndo1 on metabolic health and general health in adults with prediabetes. The primary question it aims to answer are: How does SRW Ndo1 affect the Haemoglobin A1C (HbA1C) test outcome for adult individuals? How does SRW Ndo1 affect the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- SRW Ndo1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 8 Jul 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and over.
- Prediabetes, defined as fasting plasma glucose of 6.1-6.9 mmol/L and/or HbA1c of 5.7-6.4% and/or 2 h plasma glucose of 7.8-11.0 mmol/L after ingestion of 75 g of oral glucose load. Blood tests conducted within 3 months before randomisation will be accepted.
- Able to read and write English.
- Has access to internet.
- Provided informed consent to participate in the study.
Who cannot join
- Has a medical condition known to affect the glycaemia.
- Regular intake of a health supplement with effects on glycaemia.
- Currently participating in another trial/study of a supplement or drug.
- Has any known food or allergy or intolerances to the ingredients of the intervention.
- Pregnant, trying to conceive or breastfeeding.
- Has any current substance abuse (including tobacco, alcohol and recreational drugs) or currently in substance withdrawal.
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- Moderate to severe medical conditions (defined as a significant impact on social areas of functioning).
- Any medical conditions that was not stable over the last 3 months.
- Taking any prescription medication known to affect glycaemia or had a change in their medication within the last 3 months.
- Currently taking celiprolol, metformin, or any angiotensin-converting enzyme inhibitor medications.
- Major medical or surgical event requiring hospitalization within the last 3 months.
- Any other medical reason that may make participation in this study pose a risk to the participant, including potential herb-drug interactions, at the discretion of the study medical supervisor.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to test the effect of 12 weeks of supplementation SRW Ndo1 on metabolic health and general health in adults with prediabetes. The primary question it aims to answer are:
- How does SRW Ndo1 affect the Haemoglobin A1C (HbA1C) test outcome for adult individuals?
- How does SRW Ndo1 affect the body measures and blood pressures of adult individuals?
Read more
Investigators will compare the supplement to a placebo (a look-alike substance that contains no supplement) to see if SRW Ndo1 works to support normal blood sugar metabolism.
Participants will:
- Take supplement SRW Ndo1, two capsules a day for 12 weeks.
- Be asked to refrain from changing their diet and lifestyle drastically during the study and to refrain from starting new health supplements during the study.
- Visit the clinic at the start and the end of intervention for a blood test (8 hour fasting required prior to test)
- Keep a diary of their symptoms or adverse events during intervention.
- Conditions
- Prediabetes
- Being tested
- SRW Ndo1
- Keywords
- Diabetes, prediabetes
- Medical subject headings
- Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRW Ndo1Dietary supplement
The investigational product (IP) is a health supplement for glycaemic control. Each capsule contains 80 mg of dahlia4® (Dahlia pinnata extract), 80 mg of Eriomin® (Citrus limon extract), and 100 mg of Mulberry leaf extract (with 5% 1-deoxynojirimycin).
| Study group | Role | What they receive |
|---|---|---|
| SRW Ndo1 | Experimental | Active arm
The investigational product (IP) is a health supplement that contains 80 mg of dahlia4® (Dahlia pinnata extract), 80 mg of Eriomin® (Citrus limon extract), and 100 mg of Mulberry leaf extract (with 5% 1-deoxynojirimycin) per capsule. Excipients include Microcrystalline cellulose, Magnesium stearate, and Colloidal silicon dioxide.
Participants will take two capsules of Ndo1 per day, before dinner, with water, for 12 weeks. Receives: Dietary Supplement: SRW Ndo1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Hemoglobin A1C (HbA1c) concentration
Measured in mmol/mol. Normal range: <5.7
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (13)
Fasting plasma glucose concentration
Measured in mg/dL
Measured: From enrollment to the end of treatment at 12 weeks
Weight
Measured in kg
Measured: From enrollment to the end of treatment at 12 weeks
Body Mass Index (BMI)
Measured in kg/m^2. Optimal range: 18.5-24.9.
Measured: From enrollment to the end of treatment at 12 weeks
Waist circumference
Measured in cm
Measured: From enrollment to the end of treatment at 12 weeks
Blood lipids
Total Cholesterol (TC):
Normal: <5.2 mmol/L Borderline High: 5.2-6.2 mmol/L High: ≥6.2 mmol/L
Triglycerides (TG):
Normal: <1.7 mmol/L Borderline High: 1.7-2.3 mmol/L High: ≥2.3 mmol/L
Low-Density Lipoprotein Cholesterol (LDL-C):
Normal: <3.4 mmol/L Borderline High: 3.4-4.1 mmol/L High: ≥4.1 mmol/L
High-Density Lipoprotein Cholesterol (HDL-C):
Normal for Men: >1.0 mmol/L Normal for Women: >1.3 mmol/L Low: <1.0 mmol/L for Men, <1.3 mmol/L for Women
Measured: From enrollment to the end of treatment at 12 weeks
Liver functions test
Alanine Aminotransferase (ALT):
Normal: 0-40 U/L
Aspartate Aminotransferase (AST):
Normal: 0-40 U/L
Alkaline Phosphatase (ALP):
Normal: 40-150 U/L
Total Bilirubin (TBIL):
Normal: 3.4-17.1 μmol/L
Gamma-Glutamyl Transferase (GGT):
Normal: <60 U/L for men, <40 U/L for women
Measured: From enrollment to the end of treatment at 12 weeks
Hs-CRP test
Measured in mg/L. Optimal: <1.0 mg/L
Measured: From enrollment to the end of treatment at 12 weeks
Systolic and diastolic blood pressure
Measured in mmHg. Optimal range: <120/80 mmHg.
Measured: From enrollment to the end of treatment at 12 weeks
Energy questionnaire
Measured using a 100-point Likert scale. 1 is 'extremely low energy' and 100 is 'extremely high energy'
Measured: From enrollment to the end of treatment at 12 weeks
Hunger and satiety questionnaire
Measured using a 100-point Likert scale. 1 is 'extremely unsatisfied' and 100 is 'extremely satisfied'
Measured: From enrollment to the end of treatment at 12 weeks
Mood questionnaire
Measured using a 100-point Likert scale. 1 is 'extremely stressed' and 100 is 'no stress at all'
Measured: From enrollment to the end of treatment at 12 weeks
Gastrointestinal symptoms questionnaire
Measured using a 100-point Likert scale. 1 is 'No symptoms' and 100 is 'very severe symptoms'
Measured: From enrollment to the end of treatment at 12 weeks
Hypoglycemia events frequency questionnaire
Measured using a 100-point Likert scale. 1 is 'None at all' and 100 is 'extremely high frequency'
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Apr 2025
- Primary completion1 Jul 2025
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellizen Australia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897462
- Sponsor's protocol ID
- WEL202401
- Status last verified
- Jul 2025
- First submitted
- 9 Mar 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a commercial study. Due to intellectual property issues, the individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Science Research Wellness Ndo1 on Glycaemia in Adults With Pre-diabetes
- ClinicalTrials.gov ID
- NCT06897462
- Acronym / sponsor ID
- WEL202401
- Conditions
- Prediabetes
- Keywords
- Diabetes, prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wellizen AustraliaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 27 Mar 2025 (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.
The objective of this study is to test the effect of 12 weeks of supplementation SRW Ndo1 on metabolic health and general health in adults with prediabetes. The primary question it aims to answer are:
- How does SRW Ndo1 affect the Haemoglobin A1C (HbA1C) test outcome for adult individuals?
- How does SRW Ndo1 affect the body measures and blood pressures of adult individuals?
Investigators will compare the supplement to a placebo (a look-alike substance that contains no supplement) to see if SRW Ndo1 works to support normal blood sugar metabolism.
Participants will:
- Take supplement SRW Ndo1, two capsules a day for 12 weeks.
- Be asked to refrain from changing their diet and lifestyle drastically during the study and to refrain from starting new health supplements during the study.
- Visit the clinic at the start and the end of intervention for a blood test (8 hour fasting required prior to test)
- Keep a diary of their symptoms or adverse events during intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SRW Ndo1 | Experimental | Dietary Supplement: SRW Ndo1Active arm The investigational product (IP) is a health supplement that contains 80 mg of dahlia4® (Dahlia pinnata extract), 80 mg of Eriomin® (Citrus limon extract), and 100 mg of Mulberry leaf extract (with 5% 1-deoxynojirimycin) per capsule. Excipients include Microcrystalline cellulose, Magnesium stearate, and Colloidal silicon dioxide. Participants will take two capsules of Ndo1 per day, before dinner, with water, for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years and over.
- Prediabetes, defined as fasting plasma glucose of 6.1-6.9 mmol/L and/or HbA1c of 5.7-6.4% and/or 2 h plasma glucose of 7.8-11.0 mmol/L after ingestion of 75 g of oral glucose load. Blood tests conducted within 3 months before randomisation will be accepted.
- Able to read and write English.
- Has access to internet.
- Provided informed consent to participate in the study.
Key exclusion criteria (12 listed)
- Has a medical condition known to affect the glycaemia.
- Regular intake of a health supplement with effects on glycaemia.
- Currently participating in another trial/study of a supplement or drug.
- Has any known food or allergy or intolerances to the ingredients of the intervention.
- Pregnant, trying to conceive or breastfeeding.
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 |
|---|---|---|
| SRW Ndo1The investigational product (IP) is a health supplement for glycaemic control. Each capsule contains 80 mg of dahlia4® (Dahlia pinnata extract), 80 mg of Eriomin® (Citrus limon extract), and 100 mg of Mulberry leaf extract (with 5% 1-deoxynojirimycin). | Dietary supplement | SRW Ndo1 |
Primary outcome
Serum Hemoglobin A1C (HbA1c) concentration
Time frame: From enrollment to the end of treatment at 12 weeks
Measured in mmol/mol. Normal range: <5.7
13 secondary outcomes
Fasting plasma glucose concentration
Time frame: From enrollment to the end of treatment at 12 weeks
Weight
Time frame: From enrollment to the end of treatment at 12 weeks
Body Mass Index (BMI)
Time frame: From enrollment to the end of treatment at 12 weeks
Waist circumference
Time frame: From enrollment to the end of treatment at 12 weeks
Blood lipids
Time frame: From enrollment to the end of treatment at 12 weeks
Liver functions test
Time frame: From enrollment to the end of treatment at 12 weeks
Hs-CRP test
Time frame: From enrollment to the end of treatment at 12 weeks
Systolic and diastolic blood pressure
Time frame: From enrollment to the end of treatment at 12 weeks
Energy questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
Hunger and satiety questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
Mood questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
Gastrointestinal symptoms questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
Hypoglycemia events frequency questionnaire
Time frame: From enrollment to the end of treatment at 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 24 Jul 2025.
- Individual participant dataSharing planned: No. This is a commercial study. Due to intellectual property issues, the individual participant data will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRW Ndo1 in people with Prediabetes, run by Wellizen Australia at 1 site in China.
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 12 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 24 Jul 2025. 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 China. 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?
Serum Hemoglobin A1C (HbA1c) concentration (time frame: From enrollment to the end of treatment at 12 weeks). 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 24 Jul 2025.