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Completed

NCT Number: NCT06897462

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baohua

Guangzhou, Guandong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

SRW Ndo1

Dietary 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).

Primary outcomes

  1. 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

Secondary outcomes

  1. Fasting plasma glucose concentration

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measured in mg/dL

  2. Weight

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measured in kg

  3. Body Mass Index (BMI)

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measured in kg/m^2. Optimal range: 18.5-24.9.

  4. Waist circumference

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measured in cm

  5. Blood lipids

    Time frame: From enrollment to the end of treatment at 12 weeks

    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

  6. Liver functions test

    Time frame: From enrollment to the end of treatment at 12 weeks

    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

  7. Hs-CRP test

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measured in mg/L. Optimal: <1.0 mg/L

  8. Systolic and diastolic blood pressure

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measured in mmHg. Optimal range: <120/80 mmHg.

  9. Energy questionnaire

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measured using a 100-point Likert scale. 1 is 'extremely low energy' and 100 is 'extremely high energy'

  10. Hunger and satiety questionnaire

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measured using a 100-point Likert scale. 1 is 'extremely unsatisfied' and 100 is 'extremely satisfied'

  11. Mood questionnaire

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measured using a 100-point Likert scale. 1 is 'extremely stressed' and 100 is 'no stress at all'

  12. Gastrointestinal symptoms questionnaire

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measured using a 100-point Likert scale. 1 is 'No symptoms' and 100 is 'very severe symptoms'

  13. Hypoglycemia events frequency questionnaire

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measured using a 100-point Likert scale. 1 is 'None at all' and 100 is 'extremely high frequency'

Sponsors and collaborators

Lead sponsor

Wellizen Australia

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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