The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels (Bitter-Zoet 2)

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.

Study Overview

• Status: Completed
• Conditions: Impaired Glucose Tolerance; Glucose, High Blood
• Intervention / Treatment: Other: Bitter-gourd; Other: Cucumber

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• 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: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bitter-gourd; dried bitter-gourd supplements	Other: Bitter-gourd; 12-week intervention of 3.6 grams of dried bitter-gourd supplements
ACTIVE_COMPARATOR: Cucumber; dried cucumber supplements	Other: Cucumber; 12-week intervention of 3.6 grams of 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	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in 2hour plasma glucose concentrations after a 75-gram OGTT	marker for glucose metabolism	Baseline (before supplementation (T0)) and after 12 weeks (T4)
change in HbA1c	marker for glucose metabolism	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in insulin	marker for glucose metabolism	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in HOMA-IR levels	marker for glucose metabolism	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in HOMA-B levels	marker for glucose metabolism	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in ALAT	liver enzyme (study safety parameter)	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in ASAT	liver enzyme (study safety parameter)	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in eGFR	estimated glomerular filtration rate (study safety parameter)	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in creatinine	kidney function (study safety parameter)	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Investigators: Principal Investigator: Sandra van der Haar, MSc, Stichting Wageningen Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2022
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (ACTUAL): January 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: pre-diabetes; fasting blood glucose; bitter gourd
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: NL79294.091.21

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