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The study is a parallel, double blind, controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber supplements. Research subjects will come to the research facility for a test day on four occasions, with an interval of 4 weeks. The main study parameter is fasting levels of plasma glucose.
Bitter gourd (BG) (Momordica charantia) is a highly nutritive vegetable from the cucumber family. The objective is to assess the impact of 12-weeks of BG supplementation on blood glucose levels in subjects with impaired fasting glucose levels. In a previous trial (Bitter-Zoet NL70259.081.19) the short-term effects of BG (4 weeks) were studied, but no effect was observed. In the current trial a different BG cultivar is chosen, the intervention period is prolonged, the dosage per day is higher and study subjects with slightly higher fasting blood glucose levels will be included. The study is a parallel, double blind, controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber supplements. Research subjects will come to the research facility for a test day on four occasions, with an interval of 4 weeks. The main study parameter is fasting levels of plasma glucose. Secondary outcome measures are glucose tolerance, HbA1c, insulin and HOMA-IR and HOMA-B levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bitter-gourd | Experimental | dried bitter-gourd supplements |
|
| Cucumber | Active Comparator | dried cucumber supplements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bitter-gourd | Other | 12-week intervention of 3.6 grams of dried bitter-gourd supplements |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change in fasting plasma glucose concentrations | marker for glucose metabolism | Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4) |
| Measure | Description | Time Frame |
|---|---|---|
| change in 2hour plasma glucose concentrations after a 75-gram OGTT | marker for glucose metabolism | Baseline (before supplementation (T0)) and after 12 weeks (T4) |
| change in HbA1c | marker for glucose metabolism |
| Measure | Description | Time Frame |
|---|---|---|
| change in ALAT | liver enzyme (study safety parameter) | Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4) |
| change in ASAT | liver enzyme (study safety parameter) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra van der Haar, MSc | Stichting Wageningen Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stichting Wageningen Research | Wageningen | Gelderland | 6708 WG | Netherlands |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Supplements will be labeled A and B by a scientist who is not involved in this trial.
| Cucumber |
| Other |
12-week intervention of 3.6 grams of cucumber supplements |
|
| Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4) |
| change in insulin | marker for glucose metabolism | Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4) |
| change in HOMA-IR levels | marker for glucose metabolism | Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4) |
| change in HOMA-B levels | marker for glucose metabolism | Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4) |
| Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4) |
| change in eGFR | estimated glomerular filtration rate (study safety parameter) | Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4) |
| change in creatinine | kidney function (study safety parameter) | Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4) |