Glucose, High BloodBitter-Zoet 2NCT05215210
The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels
A study testing Bitter-gourd and Cucumber in people with Glucose, High Blood and Impaired Glucose Tolerance, run by Wageningen University and Research at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Glucose, High Blood, Impaired Glucose Tolerance
- What is being tested?
- Bitter-gourd and Cucumber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Mar 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 40-75yrs
- BMI >25 kg/m2
- Having a fasting glucose >6.1 mmol/L
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
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.
Read the 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.
- Conditions
- Glucose, High Blood, Impaired Glucose Tolerance
- Being tested
- Bitter-gourd, Cucumber
- Keywords
- bitter gourd, pre-diabetes, fasting blood glucose
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bitter-gourdOther
12-week intervention of 3.6 grams of dried bitter-gourd supplements
CucumberOther
12-week intervention of 3.6 grams of cucumber supplements
| Study group | Role | What they receive |
|---|---|---|
| Bitter-gourd | Experimental | dried bitter-gourd supplements Receives: Other: Bitter-gourd |
| Cucumber | Active comparator | dried cucumber supplements Receives: Other: Cucumber |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in fasting plasma glucose concentrations
marker for glucose metabolism
Measured: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Secondary outcomes (5)
change in 2hour plasma glucose concentrations after a 75-gram OGTT
marker for glucose metabolism
Measured: Baseline (before supplementation (T0)) and after 12 weeks (T4)
change in HbA1c
marker for glucose metabolism
Measured: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in insulin
marker for glucose metabolism
Measured: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in HOMA-IR levels
marker for glucose metabolism
Measured: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in HOMA-B levels
marker for glucose metabolism
Measured: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start23 Mar 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose, High BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
- Investigators
- Sandra van der Haar, MSc, Principal investigator, Stichting Wageningen Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215210
- Sponsor's protocol ID
- NL79294.091.21
- Acronym
- Bitter-Zoet 2
- Status last verified
- Nov 2022
- First submitted
- 18 Jan 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels
- ClinicalTrials.gov ID
- NCT05215210
- Acronym / sponsor ID
- Bitter-Zoet 2 / NL79294.091.21
- Conditions
- Glucose, High Blood, Impaired Glucose Tolerance
- Keywords
- bitter gourd, pre-diabetes, fasting blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bitter-gourd | Experimental | Other: Bitter-gourddried bitter-gourd supplements |
| Cucumber | Active comparator | Other: Cucumberdried cucumber supplements |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 40-75yrs
- BMI >25 kg/m2
- Having a fasting glucose >6.1 mmol/L
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bitter-gourd12-week intervention of 3.6 grams of dried bitter-gourd supplements | Other | Bitter-gourd |
| Cucumber12-week intervention of 3.6 grams of cucumber supplements | Other | Cucumber |
Primary outcome
change in fasting plasma glucose concentrations
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
marker for glucose metabolism
5 secondary outcomes
change in 2hour plasma glucose concentrations after a 75-gram OGTT
Time frame: Baseline (before supplementation (T0)) and after 12 weeks (T4)
change in HbA1c
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in insulin
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in HOMA-IR levels
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
change in HOMA-B levels
Time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra van der Haar, MSc principal investigator
Stichting Wageningen Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bitter-gourd and Cucumber in people with Glucose, High Blood and Impaired Glucose Tolerance, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in fasting plasma glucose concentrations (time frame: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.