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The study is a randomized, cross-over, double blind, controlled trial in which study participants will receive two 4-week interventions with a washout period of 4 weeks between interventions. Study subjects will visit the research facility before and after each intervention period for a test day. In the third intervention week participants are provided with a 3-day controlled diet and glucose responses will be monitored via a continuous glucose monitoring device.
Bitter gourd (BG) (Momordica charantia), is a highly nutritive vegetable from the cucumber family. The objective is to assess the impact of 4-week BG supplementation on blood glucose levels and glucose tolerance in subjects with an impaired fasting glucose or with an impaired glucose tolerance and to evaluate how BG supplements modulate glucose response curves during meal intake. The study is a randomized, cross-over, double blind, controlled trial in which study participants will receive two 4-week interventions with a washout period of 4 weeks between interventions. Study subjects will visit the research facility before and after each intervention period for a test day. In the third intervention week participants are provided with a 3-day controlled diet and glucose responses will be monitored via a continuous glucose monitoring device. The intervention will be a 4-week intervention with 2.4g/d dried bitter-gourd supplements and a reference intervention with 2.4g/d dried cucumber supplements. The main study parameter is fasting levels of plasma glucose and 2hour plasma glucose after a 75-gram OGTT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dried bitter-gourd supplements | Experimental | 2.4 gram per day for 4 weeks |
|
| dried cucumber supplements | Active Comparator | 2.4 gram per day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dried bitter-gourd supplements | Dietary Supplement | intervention with 2.4g/d dried bitter-gourd supplements |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in fasting plasma glucose concentrations | marker for glucose metabolism | before (Week 0) and after 4 weeks of supplement intervention |
| change in 2hour plasma glucose concentrations after a 75-gram OGTT | marker for glucose metabolism | before (Week 0) and after 4 weeks of supplement intervention |
| Measure | Description | Time Frame |
|---|---|---|
| change in HbA1c | marker for glucose metabolism | before (Week 0) and after 4 weeks of supplement intervention |
| change in fructosamine | marker for glucose metabolism |
| Measure | Description | Time Frame |
|---|---|---|
| change in triglycerides (TAG) concentration | marker of lipid metabolism | before (Week 0) and after 4 weeks of supplement intervention |
| change in cholesterol | marker of lipid metabolism |
Inclusion Criteria:
age 50-75yrs
BMI >25 kg/m2
Having veins suitable for blood sampling via a catheter
Having one or more of the following criteria:
Exclusion Criteria:
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| 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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| dried cucumber supplements | Dietary Supplement | reference intervention with 2.4g/d dried cucumber supplements |
|
| before (Week 0) and after 4 weeks of supplement intervention |
| change in fasting insulin | marker for glucose metabolism | before (Week 0) and after 4 weeks of supplement intervention |
| change in 2hour plasma insulin concentrations after a 75-gram OGTT | marker for glucose metabolism | before (Week 0) and after 4 weeks of supplement intervention |
| Change in postprandial glucose concentrations after food intake | measured by a continues glucose monitoring device | Three full days, in the third week of the supplement intervention |
| before (Week 0) and after 4 weeks of supplement intervention |
| change in ALAT | Liver enzyme | before (Week 0) and after 4 weeks of supplement intervention |
| change in ASAT | Liver enzyme | before (Week 0) and after 4 weeks of supplement intervention |
| change in eGFR (CKD-EPI) | Liver enzyme | before (Week 0) and after 4 weeks of supplement intervention |