Skip to main content
OpenTrials
Completed

NCT Number: NCT05215210

The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels

The study is a parallel, double blind, controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber supplements. Research subjects will come to the research facility for a test day on four occasions, with an interval of 4 weeks. The main study parameter is fasting levels of plasma glucose.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 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 12-weeks of BG supplementation on blood glucose levels in subjects with impaired fasting glucose levels. In a previous trial (Bitter-Zoet NL70259.081.19) the short-term effects of BG (4 weeks) were studied, but no effect was observed. In the current trial a different BG cultivar is chosen, the intervention period is prolonged, the dosage per day is higher and study subjects with slightly higher fasting blood glucose levels will be included. The study is a parallel, double blind, controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber supplements. Research subjects will come to the research facility for a test day on four occasions, with an interval of 4 weeks. The main study parameter is fasting levels of plasma glucose. Secondary outcome measures are glucose tolerance, HbA1c, insulin and HOMA-IR and HOMA-B levels.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 40-75yrs
  • BMI >25 kg/m2
  • Having a fasting glucose >6.1 mmol/L

Exclusion criteria

  • Use of medication/supplements that may influence the study results, such as metformin, gliclazide, glimepiride, tolbutamide, insulin, sitagliptin (DPP4 inhibitor), liraglutide (GLP-1 agonist), acarbose, repaglinide, pioglitazone, corticosteroids (systemically) , SGLT-2 inhibitors, (judged by our research physician)
  • Having a fasting glucose >11.0 mmol/L
  • History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
  • History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
  • 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 ≥14 glasses (women) or >21 glasses (men) of alcoholic beverages per week, on average
  • pregnant or lactating (self-reported)
  • Abuse of illicit drugs (soft- and hard 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

Bitter-gourd

Other

12-week intervention of 3.6 grams of dried bitter-gourd supplements

Cucumber

Other

12-week intervention of 3.6 grams of cucumber supplements

Primary outcomes

  1. change in fasting plasma glucose concentrations

    Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

    marker for glucose metabolism

Secondary outcomes

  1. change in 2hour plasma glucose concentrations after a 75-gram OGTT

    Time frame: Baseline (before supplementation (T0)) and after 12 weeks (T4)

    marker for glucose metabolism

  2. change in HbA1c

    Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

    marker for glucose metabolism

  3. change in insulin

    Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

    marker for glucose metabolism

  4. change in HOMA-IR levels

    Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

    marker for glucose metabolism

  5. change in HOMA-B levels

    Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

    marker for glucose metabolism

Other outcomes

  1. change in ALAT

    Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

    liver enzyme (study safety parameter)

  2. change in ASAT

    Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

    liver enzyme (study safety parameter)

  3. change in eGFR

    Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

    estimated glomerular filtration rate (study safety parameter)

  4. change in creatinine

    Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

    kidney function (study safety parameter)

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Registry information

Acronym: Bitter-Zoet 2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2022
Registry last updated
Nov 7, 2022

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.

Published trials that share one or more normalized conditions with this study.