The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels (Bitter-Zoet 2)
Primary Purpose
Glucose, High Blood, Impaired Glucose Tolerance
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Bitter-gourd
Cucumber
Sponsored by
About this trial
This is an interventional treatment trial for Glucose, High Blood focused on measuring bitter gourd, pre-diabetes, fasting blood glucose
Eligibility Criteria
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.
Sites / Locations
- Stichting Wageningen Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bitter-gourd
Cucumber
Arm Description
dried bitter-gourd supplements
dried cucumber supplements
Outcomes
Primary Outcome Measures
change in fasting plasma glucose concentrations
marker for glucose metabolism
Secondary Outcome Measures
change in 2hour plasma glucose concentrations after a 75-gram OGTT
marker for glucose metabolism
change in HbA1c
marker for glucose metabolism
change in insulin
marker for glucose metabolism
change in HOMA-IR levels
marker for glucose metabolism
change in HOMA-B levels
marker for glucose metabolism
Full Information
NCT ID
NCT05215210
First Posted
January 18, 2022
Last Updated
November 4, 2022
Sponsor
Wageningen University and Research
1. Study Identification
Unique Protocol Identification Number
NCT05215210
Brief Title
The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels
Acronym
Bitter-Zoet 2
Official Title
The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University and Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose, High Blood, Impaired Glucose Tolerance
Keywords
bitter gourd, pre-diabetes, fasting blood glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Supplements will be labeled A and B by a scientist who is not involved in this trial.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bitter-gourd
Arm Type
Experimental
Arm Description
dried bitter-gourd supplements
Arm Title
Cucumber
Arm Type
Active Comparator
Arm Description
dried cucumber supplements
Intervention Type
Other
Intervention Name(s)
Bitter-gourd
Intervention Description
12-week intervention of 3.6 grams of dried bitter-gourd supplements
Intervention Type
Other
Intervention Name(s)
Cucumber
Intervention Description
12-week intervention of 3.6 grams of cucumber supplements
Primary Outcome Measure Information:
Title
change in fasting plasma glucose concentrations
Description
marker for glucose metabolism
Time Frame
Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Secondary Outcome Measure Information:
Title
change in 2hour plasma glucose concentrations after a 75-gram OGTT
Description
marker for glucose metabolism
Time Frame
Baseline (before supplementation (T0)) and after 12 weeks (T4)
Title
change in HbA1c
Description
marker for glucose metabolism
Time Frame
Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Title
change in insulin
Description
marker for glucose metabolism
Time Frame
Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Title
change in HOMA-IR levels
Description
marker for glucose metabolism
Time Frame
Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Title
change in HOMA-B levels
Description
marker for glucose metabolism
Time Frame
Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Other Pre-specified Outcome Measures:
Title
change in ALAT
Description
liver enzyme (study safety parameter)
Time Frame
Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Title
change in ASAT
Description
liver enzyme (study safety parameter)
Time Frame
Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Title
change in eGFR
Description
estimated glomerular filtration rate (study safety parameter)
Time Frame
Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Title
change in creatinine
Description
kidney function (study safety parameter)
Time Frame
Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra van der Haar, MSc
Organizational Affiliation
Stichting Wageningen Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stichting Wageningen Research
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6708 WG
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels
We'll reach out to this number within 24 hrs