The Effect of Momordica Charantia Supplementation on Blood Glucose Levels

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Momordica Charantia Supplementation on Blood Glucose Levels

Conditions
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Glucose Intolerance

Intervention / Treatment
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* Dietary Supplement: dried bitter-gourd supplements
* Dietary Supplement: dried cucumber supplements


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dried bitter-gourd supplements<br>2.4 gram per day for 4 weeks | Dietary Supplement: dried bitter-gourd supplements<br>* intervention with 2.4g/d dried bitter-gourd supplements<br>* Other names: Momordica charantia;|
| Active Comparator: dried cucumber supplements<br>2.4 gram per day for 4 weeks | Dietary Supplement: dried cucumber supplements<br>* reference intervention with 2.4g/d dried cucumber supplements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in fasting plasma glucose concentrations | marker for glucose metabolism | before (Week 0) and after 4 weeks of supplement intervention | 
| change in 2hour plasma glucose concentrations after a 75-gram OGTT | marker for glucose metabolism | before (Week 0) and after 4 weeks of supplement intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in HbA1c | marker for glucose metabolism | before (Week 0) and after 4 weeks of supplement intervention | 
| change in fructosamine | marker for glucose metabolism | before (Week 0) and after 4 weeks of supplement intervention | 
| change in fasting insulin | marker for glucose metabolism | before (Week 0) and after 4 weeks of supplement intervention | 
| change in 2hour plasma insulin concentrations after a 75-gram OGTT | marker for glucose metabolism | before (Week 0) and after 4 weeks of supplement intervention | 
| Change in postprandial glucose concentrations after food intake | measured by a continues glucose monitoring device | Three full days, in the third week of the supplement intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bitter gourd, pre-diabetics, glucose response