Clinical trial NCT04090788: The Effect of Momordica Charantia Supplementation on Blood Glucose Levels
Official title: The Effect of Momordica Charantia Supplementation on Blood Glucose Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Intolerance
Keywords: bitter gourd
pre-diabetics
glucose response
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in fasting plasma glucose concentrations
timeFrame: before (Week 0) and after 4 weeks of supplement intervention
measure: change in 2hour plasma glucose concentrations after a 75-gram OGTT
timeFrame: before (Week 0) and after 4 weeks of supplement intervention
Secondary outcomes:
measure: change in HbA1c
timeFrame: before (Week 0) and after 4 weeks of supplement intervention
measure: change in fructosamine
timeFrame: before (Week 0) and after 4 weeks of supplement intervention
measure: change in fasting insulin
timeFrame: before (Week 0) and after 4 weeks of supplement intervention
measure: change in 2hour plasma insulin concentrations after a 75-gram OGTT
timeFrame: before (Week 0) and after 4 weeks of supplement intervention
measure: Change in postprandial glucose concentrations after food intake
timeFrame: Three full days, in the third week of the supplement intervention
Other outcomes:
measure: change in triglycerides (TAG) concentration
timeFrame: before (Week 0) and after 4 weeks of supplement intervention
measure: change in cholesterol
timeFrame: before (Week 0) and after 4 weeks of supplement intervention
measure: change in ALAT
timeFrame: before (Week 0) and after 4 weeks of supplement intervention
measure: change in ASAT
timeFrame: before (Week 0) and after 4 weeks of supplement intervention
measure: change in eGFR (CKD-EPI)
timeFrame: before (Week 0) and after 4 weeks of supplement intervention
Locations:
city: Wageningen
country: Netherlands
facility: Stichting Wageningen Research
state: Gelderland
Study officials:
References: