Glucose Intolerance
Conditions
Keywords
bitter gourd, pre-diabetics, glucose response
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTdried bitter-gourd supplements
intervention with 2.4g/d dried bitter-gourd supplements
DIETARY_SUPPLEMENTdried cucumber supplements
reference intervention with 2.4g/d dried cucumber supplements
Sponsors
Wageningen University and Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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: * HbA1c \> 5.7% * fasting glucose \>5.6mmol/L * two-hour glucose levels \>7.8 mmol/L on the 75-g oral glucose tolerance test .
Exclusion criteria
* History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints * History of liver dysfunction (cirrhosis, hepatitis) or liver surgery * Kidney dysfunction (self-reported) * Use of medication/supplements that may influence the study results, such as medicines known to interfere with glucose homeostasis. * Anaemia (Hb values \<7.5 for women and \<8.5 for men) * Reported slimming, medically prescribed or other extreme diets * Reported weight loss or weight gain of \> 5 kg in the month prior to pre-study screening * Not willing to give up blood donation during the study * Current smokers * Alcohol intake ≥4 glasses of alcoholic beverages per day * Abuse of illicit drugs * Food allergies for products that we use in the study * Participation in another clinical trial at the same time * Being an employee of the Food, Health & Consumer Research group of Wageningen Food & Biobased Research or dept. human nutrition and health of Wageningen University.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in fasting plasma glucose concentrations | before (Week 0) and after 4 weeks of supplement intervention | marker for glucose metabolism |
| change in 2hour plasma glucose concentrations after a 75-gram OGTT | before (Week 0) and after 4 weeks of supplement intervention | marker for glucose metabolism |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in fructosamine | before (Week 0) and after 4 weeks of supplement intervention | marker for glucose metabolism |
| change in HbA1c | before (Week 0) and after 4 weeks of supplement intervention | marker for glucose metabolism |
| change in fasting insulin | before (Week 0) and after 4 weeks of supplement intervention | marker for glucose metabolism |
| change in 2hour plasma insulin concentrations after a 75-gram OGTT | before (Week 0) and after 4 weeks of supplement intervention | marker for glucose metabolism |
| Change in postprandial glucose concentrations after food intake | Three full days, in the third week of the supplement intervention | measured by a continues glucose monitoring device |
Other
| Measure | Time frame | Description |
|---|---|---|
| change in cholesterol | before (Week 0) and after 4 weeks of supplement intervention | marker of lipid metabolism |
| change in ASAT | before (Week 0) and after 4 weeks of supplement intervention | Liver enzyme |
| change in eGFR (CKD-EPI) | before (Week 0) and after 4 weeks of supplement intervention | Liver enzyme |
| change in ALAT | before (Week 0) and after 4 weeks of supplement intervention | Liver enzyme |
| change in triglycerides (TAG) concentration | before (Week 0) and after 4 weeks of supplement intervention | marker of lipid metabolism |
Countries
Netherlands
Outcome results
None listed