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Completed

NCT Number: NCT04090788

The Effect of Momordica Charantia Supplementation on Blood Glucose Levels

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dried bitter-gourd supplements

Dietary Supplement

intervention with 2.4g/d dried bitter-gourd supplements

Other names: Momordica charantia

dried cucumber supplements

Dietary Supplement

reference intervention with 2.4g/d dried cucumber supplements

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Registry information

Acronym: Bitter-sweet

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2019
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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