The Effect of Momordica Charantia Supplementation on Blood Glucose Levels

Glucose Intolerance Clinical Trial

— Bitter-sweet  

Official title:

The Effect of Momordica Charantia Supplementation on Blood Glucose Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04090788
• Other study ID #: NL70259.081.19
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: December 25, 2019

Study information

• Verified date: September 2019
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 25, 2019
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance

Intervention

Dietary Supplement:
• dried bitter-gourd supplements
intervention with 2.4g/d dried bitter-gourd supplements
• dried cucumber supplements
reference intervention with 2.4g/d dried cucumber supplements

Locations

Country	Name	City	State
Netherlands	Stichting Wageningen Research	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University and Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in triglycerides (TAG) concentration	marker of lipid metabolism	before (Week 0) and after 4 weeks of supplement intervention
Other	change in cholesterol	marker of lipid metabolism	before (Week 0) and after 4 weeks of supplement intervention
Other	change in ALAT	Liver enzyme	before (Week 0) and after 4 weeks of supplement intervention
Other	change in ASAT	Liver enzyme	before (Week 0) and after 4 weeks of supplement intervention
Other	change in eGFR (CKD-EPI)	Liver enzyme	before (Week 0) and after 4 weeks of supplement intervention
Primary	change in fasting plasma glucose concentrations	marker for glucose metabolism	before (Week 0) and after 4 weeks of supplement intervention
Primary	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	change in HbA1c	marker for glucose metabolism	before (Week 0) and after 4 weeks of supplement intervention
Secondary	change in fructosamine	marker for glucose metabolism	before (Week 0) and after 4 weeks of supplement intervention
Secondary	change in fasting insulin	marker for glucose metabolism	before (Week 0) and after 4 weeks of supplement intervention
Secondary	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
Secondary	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