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

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ClinicalTrials.gov Identifier: NCT04090788
Recruitment Status : Active, not recruiting
First Posted : September 16, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Diederik Esser, 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.

Condition or disease Intervention/treatment Phase
Glucose Intolerance Dietary Supplement: dried bitter-gourd supplements Dietary Supplement: dried cucumber supplements Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Momordica Charantia Supplementation on Blood Glucose Levels
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : December 24, 2019
Estimated Study Completion Date : December 25, 2019

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. change in fasting plasma glucose concentrations [ Time Frame: before (Week 0) and after 4 weeks of supplement intervention ]
    marker for glucose metabolism

  2. change in 2hour plasma glucose concentrations after a 75-gram OGTT [ Time Frame: before (Week 0) and after 4 weeks of supplement intervention ]
    marker for glucose metabolism


Secondary Outcome Measures :
  1. change in HbA1c [ Time Frame: before (Week 0) and after 4 weeks of supplement intervention ]
    marker for glucose metabolism

  2. change in fructosamine [ Time Frame: before (Week 0) and after 4 weeks of supplement intervention ]
    marker for glucose metabolism

  3. change in fasting insulin [ Time Frame: before (Week 0) and after 4 weeks of supplement intervention ]
    marker for glucose metabolism

  4. change in 2hour plasma insulin concentrations after a 75-gram OGTT [ Time Frame: before (Week 0) and after 4 weeks of supplement intervention ]
    marker for glucose metabolism

  5. Change in postprandial glucose concentrations after food intake [ Time Frame: Three full days, in the third week of the supplement intervention ]
    measured by a continues glucose monitoring device


Other Outcome Measures:
  1. change in triglycerides (TAG) concentration [ Time Frame: before (Week 0) and after 4 weeks of supplement intervention ]
    marker of lipid metabolism

  2. change in cholesterol [ Time Frame: before (Week 0) and after 4 weeks of supplement intervention ]
    marker of lipid metabolism

  3. change in ALAT [ Time Frame: before (Week 0) and after 4 weeks of supplement intervention ]
    Liver enzyme

  4. change in ASAT [ Time Frame: before (Week 0) and after 4 weeks of supplement intervention ]
    Liver enzyme

  5. change in eGFR (CKD-EPI) [ Time Frame: before (Week 0) and after 4 weeks of supplement intervention ]
    Liver enzyme



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090788


Locations
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Netherlands
Stichting Wageningen Research
Wageningen, Gelderland, Netherlands, 6708 WG
Sponsors and Collaborators
Wageningen University and Research

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Responsible Party: Diederik Esser, Project leader clinical trials, Wageningen University and Research
ClinicalTrials.gov Identifier: NCT04090788     History of Changes
Other Study ID Numbers: NL70259.081.19
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diederik Esser, Wageningen University and Research:
bitter gourd
pre-diabetics
glucose response
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases