Clinical trial NCT05215210: The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels
Official title: The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose, High Blood
Impaired Glucose Tolerance
Keywords: bitter gourd
pre-diabetes
fasting blood glucose
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change in fasting plasma glucose concentrations
timeFrame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Secondary outcomes:
measure: change in 2hour plasma glucose concentrations after a 75-gram OGTT
timeFrame: Baseline (before supplementation (T0)) and after 12 weeks (T4)
measure: change in HbA1c
timeFrame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
measure: change in insulin
timeFrame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
measure: change in HOMA-IR levels
timeFrame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
measure: change in HOMA-B levels
timeFrame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Other outcomes:
measure: change in ALAT
timeFrame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
measure: change in ASAT
timeFrame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
measure: change in eGFR
timeFrame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
measure: change in creatinine
timeFrame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Locations:
city: Wageningen
country: Netherlands
facility: Stichting Wageningen Research
state: Gelderland
Study officials:
affiliation: Stichting Wageningen Research
name: Sandra van der Haar, MSc
role: PRINCIPAL_INVESTIGATOR
References: