Glucose ToleranceHerbieNCT02065271
Herbal Preparation and Glucose Homeostasis
A study testing herbal supplement in people with Glucose Tolerance and Lipid Homeostasis, run by Wageningen University at 1 site in Netherlands.
Trial summary
Rationale: The incidence of obesity and type 2 diabetes (T2D) is increasing rapidly and accounts for a considerable part of health care costs. Herbal supplements are used in many cultures for the prevention and treatment of many different conditions. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Tolerance, Lipid Homeostasis, Vascular Function
- What is being tested?
- herbal supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to Feb 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and postmenopausal females For females: menstrual cycle absent for more than 1 year
- age 50-70yrs
- BMI >27 kg/m2
- Increased fasting glucose or an impaired glucose tolerance (two-hour glucose levels >7.8 mmol/L on the 75-g oral glucose tolerance test or fasting glucose >6.1mmol/L).
Who cannot join
- Systolic blood pressure >160mmHg and diastolic blood pressure> 100mmHg
- Tobacco smoker
- Received inoculations within 2 months of starting the study or planned during the study
- Donated or intend to donate blood from 2 months before the study till months after the study.
- Unstable body weight (weight gain or loss >5kg in the past three months)
- Diagnosed with any long-term medical condition (e.g., diabetes, haemophilia, CVD, anemia, gastrointestinal disease, renal failure, thyroid disorders, cancer, HIV, hepatitis C)
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- The use of the following medicine: medicine interfering with St Johns Worth such as, inhibitors of the immune system (ciclosporine, tacrolimus, everolimus, temsirolimus and sirolimus), coumarine type anticoagulant medicine (acenocoumarol and fenprocoumon), anti-epileptica (fenobarbital and fenytoïne), theophylline, atorvastatine, simvastatine, digoxine, kinidine, voriconazol, proton pump inhibitors (omeprazole and esomeprazole) and all anti-depressives ( incl. MAO inhibitors and SSRI's).
- Abuse of drugs/alcohol
- If the participant don't want to sign the informed consent
- If the participant don't want to be informed about unexpected findings during the screening or study
- Participation in another biomedical study
- Additional exclusion criteria for females:
- Current use of contraceptives containing hormones Current use of hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: The incidence of obesity and type 2 diabetes (T2D) is increasing rapidly and accounts for a considerable part of health care costs. Herbal supplements are used in many cultures for the prevention and treatment of many different conditions. Due to lack of scientific proof, the application in western cultures are minimal. Animal studies have shown that many constituents of such herbal supplements may have beneficial effects on several important parameters known to be affected in T2D. Still, no scientific proof in humans is available. We therefore aim to investigate the effect of 4-week herbal supplementation on glucose metabolism, lipid metabolism, vascular function and inflammation in subjects with increased fasting glucose levels or a decreased glucose tolerance.
Objective: The primary objectives are to investigate if 4-week herbal supplementation in subjects with increased fasting glucose levels or a decreased glucose tolerance has a positive effect on blood glucose levels and glucose tolerance. The secondary objectives are to investigate if 4-week herbal supplementation in subjects with increased fasting glucose levels or a decreased glucose tolerance has a positive effect on triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels, inflammation, adipose tissue and white blood cell gene-expression and AIX both fasted and during an OGTT test.
Read more
Study design: This study is a randomized, double-blind, placebo controlled cross-over trial in which two different treatments will be evaluated e.g. an intervention with the herbal mixture and a placebo. Each person will obtain both treatments in random order for four weeks with a wash out period of four weeks in-between. Fasting blood samples will be collected and subjects will receive a OGTT, paralleled by a PWA before and after 4-week supplementation.
Furthermore, after 4-week supplement intake we will collect a urine sample and collect an adipose tissue biopsy. The whole trial will last three months.
Study population: 26 overweight males and females 50-75yrs old with an increased fasting glucose or with an impaired glucose tolerance.
Intervention: Two intervention periods of 4-weeks in which participants will take three times a day a supplement of 500mg herbal or placebo.
Main study parameters/endpoints: Fasting blood glucose levels, glucose tolerance as determined by an oral glucose tolerance test (OGTT), AIX, triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels, PWA, adipose tissue an white blood cell gene expression and markers of inflammation .
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects that will participate in the study will invest a total of 16.5 hours. Blood collection by vena punctures/insertion of the venflon and the collection of an adipose tissue biopsy can occasionally cause a local hematoma or bruise and some participants may report pain or discomfort. The herbal supplements contain small amounts St. John's wort, which may affect the function of liver enzymes. We will therefore monitor liver function parameters during the supplementation period. Furthermore, subjects are excluded if they use medication known to be affected by St. John's wort. Participant will donate 284ml of blood, dispersed over 12 weeks.
- Conditions
- Glucose Tolerance, Lipid Homeostasis, Vascular Function, Inflammation
- Being tested
- herbal supplement, placebo supplement
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herbal supplementDietary supplement
placebo supplementOther
| Study group | Role | What they receive |
|---|---|---|
| herbal supplements | Experimental | 500mg, 3 per day, 4weeks Receives: Dietary Supplement: herbal supplement |
| placebo | Placebo comparator | 500mg, 3 per day, 4 weeks Receives: Other: placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in glucose tolerance
by oral glucose tolerance test (OGTT)
Measured: baseline and after 4-week supplementation
Secondary outcomes (5)
change in insulin
Measured: baseline and after 4-week supplementation
change in TAG
Measured: baseline and after 4 week supplementation
change in HbA1c
glycosylated haemoglobin
Measured: baseline and after 4 week supplementation
change in FFA
Measured: baseline and after 4 week supplementation
change in cholesterol
Measured: baseline and after 4 week supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose ToleranceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- lydia a afman, phd, Study director, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065271
- Sponsor's protocol ID
- NL44919.081.13
- Acronym
- Herbie
- Status last verified
- Feb 2014
- First submitted
- 9 Dec 2013
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herbal Preparation and Glucose Homeostasis
- ClinicalTrials.gov ID
- NCT02065271
- Acronym / sponsor ID
- Herbie / NL44919.081.13
- Conditions
- Glucose Tolerance, Lipid Homeostasis, Vascular Function, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Feb 2014 (estimated)
- 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.
Rationale: The incidence of obesity and type 2 diabetes (T2D) is increasing rapidly and accounts for a considerable part of health care costs. Herbal supplements are used in many cultures for the prevention and treatment of many different conditions. Due to lack of scientific proof, the application in western cultures are minimal. Animal studies have shown that many constituents of such herbal supplements may have beneficial effects on several important parameters known to be affected in T2D. Still, no scientific proof in humans is available. We therefore aim to investigate the effect of 4-week herbal supplementation on glucose metabolism, lipid metabolism, vascular function and inflammation in subjects with increased fasting glucose levels or a decreased glucose tolerance.
Objective: The primary objectives are to investigate if 4-week herbal supplementation in subjects with increased fasting glucose levels or a decreased glucose tolerance has a positive effect on blood glucose levels and glucose tolerance. The secondary objectives are to investigate if 4-week herbal supplementation in subjects with increased fasting glucose levels or a decreased glucose tolerance has a positive effect on triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels, inflammation, adipose tissue and white blood cell gene-expression and AIX both fasted and during an OGTT test.
Study design: This study is a randomized, double-blind, placebo controlled cross-over trial in which two different treatments will be evaluated e.g. an intervention with the herbal mixture and a placebo. Each person will obtain both treatments in random order for four weeks with a wash out period of four weeks in-between. Fasting blood samples will be collected and subjects will receive a OGTT, paralleled by a PWA before and after 4-week supplementation.
Furthermore, after 4-week supplement intake we will collect a urine sample and collect an adipose tissue biopsy. The whole trial will last three months.
Study population: 26 overweight males and females 50-75yrs old with an increased fasting glucose or with an impaired glucose tolerance.
Intervention: Two intervention periods of 4-weeks in which participants will take three times a day a supplement of 500mg herbal or placebo.
Main study parameters/endpoints: Fasting blood glucose levels, glucose tolerance as determined by an oral glucose tolerance test (OGTT), AIX, triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels, PWA, adipose tissue an white blood cell gene expression and markers of inflammation .
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects that will participate in the study will invest a total of 16.5 hours. Blood collection by vena punctures/insertion of the venflon and the collection of an adipose tissue biopsy can occasionally cause a local hematoma or bruise and some participants may report pain or discomfort. The herbal supplements contain small amounts St. John's wort, which may affect the function of liver enzymes. We will therefore monitor liver function parameters during the supplementation period. Furthermore, subjects are excluded if they use medication known to be affected by St. John's wort. Participant will donate 284ml of blood, dispersed over 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| herbal supplements | Experimental | Dietary Supplement: herbal supplement500mg, 3 per day, 4weeks |
| placebo | Placebo comparator | Other: placebo supplement500mg, 3 per day, 4 weeks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and postmenopausal females For females: menstrual cycle absent for more than 1 year
- age 50-70yrs
- BMI >27 kg/m2
- Increased fasting glucose or an impaired glucose tolerance (two-hour glucose levels >7.8 mmol/L on the 75-g oral glucose tolerance test or fasting glucose >6.1mmol/L).
Key exclusion criteria (13 listed)
- Systolic blood pressure >160mmHg and diastolic blood pressure> 100mmHg
- Tobacco smoker
- Received inoculations within 2 months of starting the study or planned during the study
- Donated or intend to donate blood from 2 months before the study till months after the study.
- Unstable body weight (weight gain or loss >5kg in the past three months)
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 |
|---|---|---|
| herbal supplement | Dietary supplement | herbal supplements |
| placebo supplement | Other | placebo |
Primary outcome
change in glucose tolerance
Time frame: baseline and after 4-week supplementation
by oral glucose tolerance test (OGTT)
5 secondary outcomes
change in insulin
Time frame: baseline and after 4-week supplementation
change in TAG
Time frame: baseline and after 4 week supplementation
change in HbA1c
Time frame: baseline and after 4 week supplementation
change in FFA
Time frame: baseline and after 4 week supplementation
change in cholesterol
Time frame: baseline and after 4 week supplementation
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 17 Feb 2014.
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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.
lydia a afman, phd study director
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing herbal supplement in people with Glucose Tolerance and Lipid Homeostasis, run by Wageningen University 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 4 inclusion and 13 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 17 Feb 2014. 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. Some participants in this study may receive a placebo. 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 glucose tolerance (time frame: baseline and after 4-week supplementation). 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 17 Feb 2014.