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

Primary Purpose

Glucose Intolerance

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
dried bitter-gourd supplements
dried cucumber supplements
Sponsored by
Wageningen University and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glucose Intolerance focused on measuring bitter gourd, pre-diabetics, glucose response

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stichting Wageningen Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dried bitter-gourd supplements

dried cucumber supplements

Arm Description

2.4 gram per day for 4 weeks

2.4 gram per day for 4 weeks

Outcomes

Primary Outcome Measures

change in fasting plasma glucose concentrations
marker for glucose metabolism
change in 2hour plasma glucose concentrations after a 75-gram OGTT
marker for glucose metabolism

Secondary Outcome Measures

change in HbA1c
marker for glucose metabolism
change in fructosamine
marker for glucose metabolism
change in fasting insulin
marker for glucose metabolism
change in 2hour plasma insulin concentrations after a 75-gram OGTT
marker for glucose metabolism
Change in postprandial glucose concentrations after food intake
measured by a continues glucose monitoring device

Full Information

First Posted
September 10, 2019
Last Updated
October 9, 2020
Sponsor
Wageningen University and Research
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1. Study Identification

Unique Protocol Identification Number
NCT04090788
Brief Title
The Effect of Momordica Charantia Supplementation on Blood Glucose Levels
Acronym
Bitter-sweet
Official Title
The Effect of Momordica Charantia Supplementation on Blood Glucose Levels
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
December 24, 2019 (Actual)
Study Completion Date
December 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance
Keywords
bitter gourd, pre-diabetics, glucose response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dried bitter-gourd supplements
Arm Type
Experimental
Arm Description
2.4 gram per day for 4 weeks
Arm Title
dried cucumber supplements
Arm Type
Active Comparator
Arm Description
2.4 gram per day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
dried bitter-gourd supplements
Other Intervention Name(s)
Momordica charantia
Intervention Description
intervention with 2.4g/d dried bitter-gourd supplements
Intervention Type
Dietary Supplement
Intervention Name(s)
dried cucumber supplements
Intervention Description
reference intervention with 2.4g/d dried cucumber supplements
Primary Outcome Measure Information:
Title
change in fasting plasma glucose concentrations
Description
marker for glucose metabolism
Time Frame
before (Week 0) and after 4 weeks of supplement intervention
Title
change in 2hour plasma glucose concentrations after a 75-gram OGTT
Description
marker for glucose metabolism
Time Frame
before (Week 0) and after 4 weeks of supplement intervention
Secondary Outcome Measure Information:
Title
change in HbA1c
Description
marker for glucose metabolism
Time Frame
before (Week 0) and after 4 weeks of supplement intervention
Title
change in fructosamine
Description
marker for glucose metabolism
Time Frame
before (Week 0) and after 4 weeks of supplement intervention
Title
change in fasting insulin
Description
marker for glucose metabolism
Time Frame
before (Week 0) and after 4 weeks of supplement intervention
Title
change in 2hour plasma insulin concentrations after a 75-gram OGTT
Description
marker for glucose metabolism
Time Frame
before (Week 0) and after 4 weeks of supplement intervention
Title
Change in postprandial glucose concentrations after food intake
Description
measured by a continues glucose monitoring device
Time Frame
Three full days, in the third week of the supplement intervention
Other Pre-specified Outcome Measures:
Title
change in triglycerides (TAG) concentration
Description
marker of lipid metabolism
Time Frame
before (Week 0) and after 4 weeks of supplement intervention
Title
change in cholesterol
Description
marker of lipid metabolism
Time Frame
before (Week 0) and after 4 weeks of supplement intervention
Title
change in ALAT
Description
Liver enzyme
Time Frame
before (Week 0) and after 4 weeks of supplement intervention
Title
change in ASAT
Description
Liver enzyme
Time Frame
before (Week 0) and after 4 weeks of supplement intervention
Title
change in eGFR (CKD-EPI)
Description
Liver enzyme
Time Frame
before (Week 0) and after 4 weeks of supplement intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Stichting Wageningen Research
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6708 WG
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Momordica Charantia Supplementation on Blood Glucose Levels

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