The Effect of Momordica Charantia Supplementation on Blood Glucose Levels (Bitter-sweet)

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.

Study Overview

• Status: Completed
• Conditions: Glucose Intolerance
• Intervention / Treatment: Dietary supplement: dried bitter-gourd supplements; Dietary supplement: dried cucumber supplements

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Stichting Wageningen Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dried bitter-gourd supplements; 2.4 gram per day for 4 weeks	Dietary supplement: dried bitter-gourd supplements; intervention with 2.4g/d dried bitter-gourd supplements; Other Names: Momordica charantia
Active Comparator: dried cucumber supplements; 2.4 gram per day for 4 weeks	Dietary supplement: dried cucumber supplements; reference intervention with 2.4g/d dried cucumber supplements

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in triglycerides (TAG) concentration	marker of lipid metabolism	before (Week 0) and after 4 weeks of supplement intervention
change in cholesterol	marker of lipid metabolism	before (Week 0) and after 4 weeks of supplement intervention
change in ALAT	Liver enzyme	before (Week 0) and after 4 weeks of supplement intervention
change in ASAT	Liver enzyme	before (Week 0) and after 4 weeks of supplement intervention
change in eGFR (CKD-EPI)	Liver enzyme	before (Week 0) and after 4 weeks of supplement intervention

Collaborators and Investigators

• Sponsor: Wageningen University and Research

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): December 24, 2019
• Study Completion (Actual): December 25, 2019

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: glucose response; bitter gourd; pre-diabetics
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: NL70259.081.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No