The Effect of Momordica Charantia Supplementation on Blood Glucose Levels

NCT ID: NCT04090788

Last Updated: 2020-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2019-12-25

Brief Summary

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.

Detailed Description

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.

Conditions

Glucose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

dried bitter-gourd supplements

2.4 gram per day for 4 weeks

Group Type: EXPERIMENTAL

dried bitter-gourd supplements

Intervention Type: DIETARY_SUPPLEMENT

intervention with 2.4g/d dried bitter-gourd supplements

dried cucumber supplements

2.4 gram per day for 4 weeks

Group Type: ACTIVE_COMPARATOR

dried cucumber supplements

Intervention Type: DIETARY_SUPPLEMENT

reference intervention with 2.4g/d dried cucumber supplements

Interventions

dried bitter-gourd supplements

intervention with 2.4g/d dried bitter-gourd supplements

Intervention Type: DIETARY_SUPPLEMENT

dried cucumber supplements

reference intervention with 2.4g/d dried cucumber supplements

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Momordica charantia

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wageningen University and Research

OTHER

Sponsor Role: lead

Responsible Party

Diederik Esser

Project leader clinical trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stichting Wageningen Research

Wageningen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL70259.081.19

Identifier Type: -

Identifier Source: org_study_id