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

Impaired Glucose Tolerance Clinical Trial

— Bitter-Zoet 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05215210
• Other study ID #: NL79294.091.21
• Status: Completed
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Glucose, High Blood
• Impaired Glucose Tolerance

Intervention

Other:
• Bitter-gourd
12-week intervention of 3.6 grams of dried bitter-gourd supplements
• Cucumber
12-week intervention of 3.6 grams of cucumber supplements

Locations

Country	Name	City	State
Netherlands	Stichting Wageningen Research	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University and Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in ALAT	liver enzyme (study safety parameter)	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Other	change in ASAT	liver enzyme (study safety parameter)	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Other	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)
Other	change in creatinine	kidney function (study safety parameter)	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Primary	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	change in 2hour plasma glucose concentrations after a 75-gram OGTT	marker for glucose metabolism	Baseline (before supplementation (T0)) and after 12 weeks (T4)
Secondary	change in HbA1c	marker for glucose metabolism	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Secondary	change in insulin	marker for glucose metabolism	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Secondary	change in HOMA-IR levels	marker for glucose metabolism	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Secondary	change in HOMA-B levels	marker for glucose metabolism	Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)