Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG, Netherlands
NCT Number: NCT04090788
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.
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Notify Me50 year–75 year
All sexes
Interventional
Not applicable
Wageningen, Gelderland, 6708 WG, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intervention with 2.4g/d dried bitter-gourd supplements
Other names: Momordica charantia
reference intervention with 2.4g/d dried cucumber supplements
Time frame: before (Week 0) and after 4 weeks of supplement intervention
marker for glucose metabolism
Time frame: before (Week 0) and after 4 weeks of supplement intervention
marker for glucose metabolism
Time frame: before (Week 0) and after 4 weeks of supplement intervention
marker for glucose metabolism
Time frame: before (Week 0) and after 4 weeks of supplement intervention
marker for glucose metabolism
Time frame: before (Week 0) and after 4 weeks of supplement intervention
marker for glucose metabolism
Time frame: before (Week 0) and after 4 weeks of supplement intervention
marker for glucose metabolism
Time frame: Three full days, in the third week of the supplement intervention
measured by a continues glucose monitoring device
Time frame: before (Week 0) and after 4 weeks of supplement intervention
marker of lipid metabolism
Time frame: before (Week 0) and after 4 weeks of supplement intervention
marker of lipid metabolism
Time frame: before (Week 0) and after 4 weeks of supplement intervention
Liver enzyme
Time frame: before (Week 0) and after 4 weeks of supplement intervention
Liver enzyme
Time frame: before (Week 0) and after 4 weeks of supplement intervention
Liver enzyme
Wageningen University and Research
Other
Acronym: Bitter-sweet
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