Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG, Netherlands
NCT Number: NCT05215210
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.
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Notify Me40 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 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12-week intervention of 3.6 grams of dried bitter-gourd supplements
12-week intervention of 3.6 grams of cucumber supplements
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
marker for glucose metabolism
Time frame: Baseline (before supplementation (T0)) and after 12 weeks (T4)
marker for glucose metabolism
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
marker for glucose metabolism
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
marker for glucose metabolism
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
marker for glucose metabolism
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
marker for glucose metabolism
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
liver enzyme (study safety parameter)
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
liver enzyme (study safety parameter)
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
estimated glomerular filtration rate (study safety parameter)
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
kidney function (study safety parameter)
Wageningen University and Research
Other
Acronym: Bitter-Zoet 2
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