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

Not Applicable

Completed

• Conditions: Impaired Glucose Tolerance; Glucose, High Blood
• Interventions: Other: Cucumber; Other: Bitter-gourd

• Registration Number: NCT05215210
• Lead Sponsor: Wageningen University and Research

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-01-31
• Study Start: 2022-03-23
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cucumber	Cucumber	dried cucumber supplements
Bitter-gourd	Bitter-gourd	dried bitter-gourd supplements

Primary Outcome Measures

Name	Time	Method
change in fasting plasma glucose concentrations	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)	marker for glucose metabolism

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stichting Wageningen Research; 🇳🇱 Wageningen, Gelderland, Netherlands