Status:
COMPLETED
The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels
Lead Sponsor:
Wageningen University and Research
Conditions:
Glucose, High Blood
Impaired Glucose Tolerance
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
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...
Detailed Description
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 sub...
Eligibility Criteria
Inclusion
- age 40-75yrs
- BMI \>25 kg/m2
- Having a fasting glucose \>6.1 mmol/L
Exclusion
- Use of medication/supplements that may influence the study results, such as metformin, gliclazide, glimepiride, tolbutamide, insulin, sitagliptin (DPP4 inhibitor), liraglutide (GLP-1 agonist), acarbose, repaglinide, pioglitazone, corticosteroids (systemically) , SGLT-2 inhibitors, (judged by our research physician)
- Having a fasting glucose \>11.0 mmol/L
- History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
- History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
- 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 ≥14 glasses (women) or \>21 glasses (men) of alcoholic beverages per week, on average
- pregnant or lactating (self-reported)
- Abuse of illicit drugs (soft- and hard 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.
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05215210
Start Date
March 23 2022
End Date
June 30 2022
Last Update
November 7 2022
Active Locations (1)
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1
Stichting Wageningen Research
Wageningen, Gelderland, Netherlands, 6708 WG