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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
intervention with 2.4g/d dried bitter-gourd supplements
reference intervention with 2.4g/d dried cucumber supplements
Stichting Wageningen Research
Wageningen, Gelderland, Netherlands
change in fasting plasma glucose concentrations
marker for glucose metabolism
Time frame: 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
Time frame: before (Week 0) and after 4 weeks of supplement intervention
change in HbA1c
marker for glucose metabolism
Time frame: before (Week 0) and after 4 weeks of supplement intervention
change in fructosamine
marker for glucose metabolism
Time frame: before (Week 0) and after 4 weeks of supplement intervention
change in fasting insulin
marker for glucose metabolism
Time frame: 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
Time frame: 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
Time frame: Three full days, in the third week of the supplement intervention
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