Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baohua | Guangzhou | Guandong | China |
This is a commercial study. Due to intellectual property issues, the individual participant data will not be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |