Effect of Science Research Wellness Ndo1 on Glycaemia in Adults With Pre-diabetes

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 Overview

• Status: Completed
• Conditions: Prediabetes
• Intervention / Treatment: Dietary supplement: SRW Ndo1

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guandong
    • Guangzhou, Guandong, China
      • Baohua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 18 years and over.
2. 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.
3. Able to read and write English.
4. Has access to internet.
5. Provided informed consent to participate in the study.

Exclusion Criteria:

1. Has a medical condition known to affect the glycaemia.
2. Regular intake of a health supplement with effects on glycaemia.
3. Currently participating in another trial/study of a supplement or drug.
4. Has any known food or allergy or intolerances to the ingredients of the intervention.
5. Pregnant, trying to conceive or breastfeeding.
6. Has any current substance abuse (including tobacco, alcohol and recreational drugs) or currently in substance withdrawal.
7. Moderate to severe medical conditions (defined as a significant impact on social areas of functioning).
8. Any medical conditions that was not stable over the last 3 months.
9. Taking any prescription medication known to affect glycaemia or had a change in their medication within the last 3 months.
10. Currently taking celiprolol, metformin, or any angiotensin-converting enzyme inhibitor medications.
11. Major medical or surgical event requiring hospitalization within the last 3 months.
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SRW Ndo1; 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.

Dietary supplement: SRW Ndo1; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Hemoglobin A1C (HbA1c) concentration	Measured in mmol/mol. Normal range: <5.7	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting plasma glucose concentration	Measured in mg/dL	From enrollment to the end of treatment at 12 weeks
Weight	Measured in kg	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.	From enrollment to the end of treatment at 12 weeks
Waist circumference	Measured in cm	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	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	From enrollment to the end of treatment at 12 weeks
Hs-CRP test	Measured in mg/L. Optimal: <1.0 mg/L	From enrollment to the end of treatment at 12 weeks
Systolic and diastolic blood pressure	Measured in mmHg. Optimal range: <120/80 mmHg.	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'	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'	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'	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'	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'	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Wellizen Australia

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 8, 2025

Study Registration Dates

• First Submitted: March 9, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 20, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; prediabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: WEL202401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a commercial study. Due to intellectual property issues, the individual participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No