Prediabetes
Conditions
Keywords
Diabetes, prediabetes
Brief 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 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.
Interventions
DIETARY_SUPPLEMENTSRW 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).
Sponsors
Wellizen Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Hemoglobin A1C (HbA1c) concentration | From enrollment to the end of treatment at 12 weeks | Measured in mmol/mol. Normal range: \<5.7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | From enrollment to the end of treatment at 12 weeks | Measured in kg |
| Body Mass Index (BMI) | From enrollment to the end of treatment at 12 weeks | Measured in kg/m\^2. Optimal range: 18.5-24.9. |
| Waist circumference | From enrollment to the end of treatment at 12 weeks | Measured in cm |
| Blood lipids | 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 |
| Liver functions test | 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 |
| Hs-CRP test | From enrollment to the end of treatment at 12 weeks | Measured in mg/L. Optimal: \<1.0 mg/L |
| Fasting plasma glucose concentration | From enrollment to the end of treatment at 12 weeks | Measured in mg/dL |
| Energy questionnaire | 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' |
| Hunger and satiety questionnaire | 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' |
| Mood questionnaire | 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' |
| Gastrointestinal symptoms questionnaire | 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' |
| Hypoglycemia events frequency questionnaire | 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' |
| Systolic and diastolic blood pressure | From enrollment to the end of treatment at 12 weeks | Measured in mmHg. Optimal range: \<120/80 mmHg. |
Countries
China
Outcome results
None listed