Glucose IntoleranceBitter-sweetNCT04090788
The Effect of Momordica Charantia Supplementation on Blood Glucose Levels
A study testing dried bitter-gourd supplements and dried cucumber supplements in people with Glucose Intolerance, run by Wageningen University and Research at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Glucose Intolerance
- What is being tested?
- dried bitter-gourd supplements and dried cucumber supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Sep 2019to 25 Dec 2019
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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
Show all 14Show fewer
- 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.
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 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.
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 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
- Being tested
- dried bitter-gourd supplements, dried cucumber supplements
- Keywords
- bitter gourd, pre-diabetics, glucose response
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dried bitter-gourd supplementsDietary supplement
Also called Momordica charantia
intervention with 2.4g/d dried bitter-gourd supplements
dried cucumber supplementsDietary supplement
reference intervention with 2.4g/d dried cucumber supplements
| Study group | Role | What they receive |
|---|---|---|
| dried bitter-gourd supplements | Experimental | 2.4 gram per day for 4 weeks Receives: Dietary Supplement: dried bitter-gourd supplements |
| dried cucumber supplements | Active comparator | 2.4 gram per day for 4 weeks Receives: Dietary Supplement: dried cucumber supplements |
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: before (Week 0) and after 4 weeks of supplement intervention
change in 2hour plasma glucose concentrations after a 75-gram OGTT
marker for glucose metabolism
Measured: before (Week 0) and after 4 weeks of supplement intervention
Secondary outcomes (5)
change in HbA1c
marker for glucose metabolism
Measured: before (Week 0) and after 4 weeks of supplement intervention
change in fructosamine
marker for glucose metabolism
Measured: before (Week 0) and after 4 weeks of supplement intervention
change in fasting insulin
marker for glucose metabolism
Measured: before (Week 0) and after 4 weeks of supplement intervention
change in 2hour plasma insulin concentrations after a 75-gram OGTT
marker for glucose metabolism
Measured: before (Week 0) and after 4 weeks of supplement intervention
Change in postprandial glucose concentrations after food intake
measured by a continues glucose monitoring device
Measured: Three full days, in the third week of the supplement intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start17 Sep 2019
- Primary completion24 Dec 2019
- Study completion25 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090788
- Sponsor's protocol ID
- NL70259.081.19
- Acronym
- Bitter-sweet
- Status last verified
- Sep 2019
- First submitted
- 10 Sep 2019
- Last updated
- 12 Oct 2020
- 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 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Momordica Charantia Supplementation on Blood Glucose Levels
- ClinicalTrials.gov ID
- NCT04090788
- Acronym / sponsor ID
- Bitter-sweet / NL70259.081.19
- Conditions
- Glucose Intolerance
- Keywords
- bitter gourd, pre-diabetics, glucose response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 16 Sep 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dried bitter-gourd supplements | Experimental | Dietary Supplement: dried bitter-gourd supplements2.4 gram per day for 4 weeks |
| dried cucumber supplements | Active comparator | Dietary Supplement: dried cucumber supplements2.4 gram per day for 4 weeks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 50-75yrs
- BMI >25 kg/m2
- Having veins suitable for blood sampling via a catheter
- Having one or more of the following criteria:
Key exclusion criteria (14 listed)
- 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)
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 |
|---|---|---|
| dried bitter-gourd supplementsAlso: Momordica charantiaintervention with 2.4g/d dried bitter-gourd supplements | Dietary supplement | dried bitter-gourd supplements |
| dried cucumber supplementsreference intervention with 2.4g/d dried cucumber supplements | Dietary supplement | dried cucumber supplements |
Primary outcome
change in fasting plasma glucose concentrations
Time frame: before (Week 0) and after 4 weeks of supplement intervention
marker for glucose metabolism
change in 2hour plasma glucose concentrations after a 75-gram OGTT
Time frame: before (Week 0) and after 4 weeks of supplement intervention
marker for glucose metabolism
5 secondary outcomes
change in HbA1c
Time frame: before (Week 0) and after 4 weeks of supplement intervention
change in fructosamine
Time frame: before (Week 0) and after 4 weeks of supplement intervention
change in fasting insulin
Time frame: before (Week 0) and after 4 weeks of supplement intervention
change in 2hour plasma insulin concentrations after a 75-gram OGTT
Time frame: before (Week 0) and after 4 weeks of supplement intervention
Change in postprandial glucose concentrations after food intake
Time frame: Three full days, in the third week of the supplement intervention
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 12 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Glucose Intolerance
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dried bitter-gourd supplements and dried cucumber supplements in people with Glucose Intolerance, 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 7 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 12 Oct 2020. 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: before (Week 0) and after 4 weeks of supplement intervention). The study lists 2 primary outcomes in all. 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 12 Oct 2020.