The Effect of Momordica Charantia Supplementation on Blood Glucose Levels

Not Applicable

Completed

• Conditions: Glucose Intolerance
• Interventions: Dietary Supplement: dried bitter-gourd supplements; Dietary Supplement: dried cucumber supplements

• Registration Number: NCT04090788
• Lead Sponsor: Wageningen University and Research

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.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-16
• Study Start: 2019-09-17
• Primary Completion: 2019-12-24
• Study Completion: 2019-12-25
• Last Update Submitted: 2020-10-09
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
dried bitter-gourd supplements	dried bitter-gourd supplements	2.4 gram per day for 4 weeks
dried cucumber supplements	dried cucumber supplements	2.4 gram per day for 4 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
change in HbA1c	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
change in fructosamine	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 fasting insulin	before (Week 0) and after 4 weeks of supplement intervention	marker for glucose metabolism

Trial Locations

Locations (1)

Stichting Wageningen Research; 🇳🇱 Wageningen, Gelderland, Netherlands