Metabolic SyndromePhase 2NCT02610491
The Effect of Hesperidin on Glucose / Insulin Metabolism
A Phase 2 study testing Hesperidin in people with Metabolic Syndrome and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Metabolic Syndrome (MS) is a well-known group of obesity-related metabolic disorders including insulin resistance (IR), dyslipidemia and hypertension (HTN). In addition, overweight has a causal relationship with a chronic low grade systemic inflammatory condition and increased intestinal permeability. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Hesperidin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2015to Oct 2015
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects at risk for metabolic syndrome: a combination of 2 out of 5 components:
- Waist circumference: men > 102 cm / women > 88 cm
- Triglycerides: ≥ 1.7 mmol/l
- HDL-cholesterol: men ≤ 1.0 mmol/l / women ≤ 1.3 mmol/l
- Systolic blood pressure: ≥ 130 mmHg or diastolic blood pressure: ≥ 85 mmHg
- Fasted serum glucose ≥ 6.1 mmol/L
Who cannot join
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥7.0 mmol/l)
- Gastroenterological diseases or abdominal surgery
- Cardiovascular diseases, cancer, liver or kidney malfunction, thyroid disorders, disease with a life expectancy shorter than 5 years
- Self-admitted HIV-positive status
- Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
- Smoking
Show all 17Show fewer
- Plans to lose weight or following a hypocaloric diet during the study period
- Weight gain or loss > 3 kg in previous 3 months
- Use of medication interfering with endpoints
- Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
- Hormone replacement therapy (women).
- Use of antibiotics in the 90 days prior to the start of study
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
- Known pregnancy (assessed by a pregnancy test before start of study) or lactation
- Blood donation within 3 months before study period
- Failure to comply prohibited intake of hesperidin containing food products during study period. A list with forbidden products will be provided to participants
- History of any side effects towards the intake of flavonoids or citrus fruits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hesperidin Administration on Glucose / Insulin Metabolism
Metabolic Syndrome (MS) is a well-known group of obesity-related metabolic disorders including insulin resistance (IR), dyslipidemia and hypertension (HTN). In addition, overweight has a causal relationship with a chronic low grade systemic inflammatory condition and increased intestinal permeability. Over the last decade, this multiplex disorder has progressively become a major worldwide public health problem, because of its association with increased risk of type 2 diabetes mellitus (DM2), atherosclerotic cardiovascular disease and all-cause mortality. Scientific evidence for measures to improve cardiometabolic and intestinal health by non-pharmaceutical means are of urgent need. Administration of the flavonoid hesperidin to those at risk may have beneficial effects on glucose / insulin metabolism, lipid metabolism, blood pressure, heart rate, pro-inflammatory and oxidative stress biomarkers and gut barrier function.
Objective: To determine the 12-week effect of daily administration of hesperidin on the main cardiometabolic disorders related to MS as assessed by investigation of glucose/insulin metabolism, blood lipid profile, blood pressure, heart rate, body composition and gut barrier function in subjects at risk for MS.
Read more
Study design: This is a randomized, double-blind, placebo-controlled study with parallel design.
Study population: Healthy (male/female) volunteers, age 18-65, at risk for metabolic syndrome (presenting with 2 out of 5 of the components from NCEP-ATP-III criteria).
Intervention: Participants will be randomly assigned to one of the intervention groups. One group will receive one daily dose of hesperidin capsules while the other group receives identical looking placebo capsules for a period of 12 weeks. The capsules will have to be ingested with a glass of water every morning just before breakfast.
Main study parameters/endpoints: The primary efficacy parameter of this study is the oral glucose tolerance test (OGTT), a validated surrogate endpoint to study the β-cell function and insulin sensitivity. Secondary endpoints entail the evaluation of effects of daily administration of hesperidin on lipid profile (blood measurements), blood pressure and heart rate, body composition, low-grade inflammation biomarkers (blood measurements) and gut barrier function (blood measurements, fecal samples, urine collection).
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Hesperidin, Placebo
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HesperidinDietary supplement
Citrus peel extract
PlaceboDietary supplement
Cellulose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Cellulose Receives: Dietary Supplement: Placebo |
| Hesperidin | Active comparator | Citrus peel extract Receives: Dietary Supplement: Hesperidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on blood glucose concentrations measured by oral glucose tolerance test
Measured: 12 weeks
Secondary outcomes (6)
Effect on blood lipid profile
Measured: 12 weeks
Effect on blood pressure
Measured: 12 weeks
Effect on body composition measured by BMI
Measured: 12 weeks
Effect on low-grade inflammation measured by blood concentration of TNFalfa
Measured: 12 weeks
Effect on low-grade inflammation measured by blood concentration of interleukin-6
Measured: 12 weeks
Effect on gut barrier function measured by a sugar test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bouke Salden, Maastricht University Medical Center
- Investigators
- Ad Masclee, MD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610491
- Sponsor's protocol ID
- 143036
- Status last verified
- Nov 2015
- First submitted
- 16 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hesperidin Administration on Glucose / Insulin Metabolism
- ClinicalTrials.gov ID
- NCT02610491
- Acronym / sponsor ID
- 143036
- Conditions
- Metabolic Syndrome, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Nov 2015 (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.
Metabolic Syndrome (MS) is a well-known group of obesity-related metabolic disorders including insulin resistance (IR), dyslipidemia and hypertension (HTN). In addition, overweight has a causal relationship with a chronic low grade systemic inflammatory condition and increased intestinal permeability. Over the last decade, this multiplex disorder has progressively become a major worldwide public health problem, because of its association with increased risk of type 2 diabetes mellitus (DM2), atherosclerotic cardiovascular disease and all-cause mortality. Scientific evidence for measures to improve cardiometabolic and intestinal health by non-pharmaceutical means are of urgent need. Administration of the flavonoid hesperidin to those at risk may have beneficial effects on glucose / insulin metabolism, lipid metabolism, blood pressure, heart rate, pro-inflammatory and oxidative stress biomarkers and gut barrier function.
Objective: To determine the 12-week effect of daily administration of hesperidin on the main cardiometabolic disorders related to MS as assessed by investigation of glucose/insulin metabolism, blood lipid profile, blood pressure, heart rate, body composition and gut barrier function in subjects at risk for MS.
Study design: This is a randomized, double-blind, placebo-controlled study with parallel design.
Study population: Healthy (male/female) volunteers, age 18-65, at risk for metabolic syndrome (presenting with 2 out of 5 of the components from NCEP-ATP-III criteria).
Intervention: Participants will be randomly assigned to one of the intervention groups. One group will receive one daily dose of hesperidin capsules while the other group receives identical looking placebo capsules for a period of 12 weeks. The capsules will have to be ingested with a glass of water every morning just before breakfast.
Main study parameters/endpoints: The primary efficacy parameter of this study is the oral glucose tolerance test (OGTT), a validated surrogate endpoint to study the β-cell function and insulin sensitivity. Secondary endpoints entail the evaluation of effects of daily administration of hesperidin on lipid profile (blood measurements), blood pressure and heart rate, body composition, low-grade inflammation biomarkers (blood measurements) and gut barrier function (blood measurements, fecal samples, urine collection).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCellulose |
| Hesperidin | Active comparator | Dietary Supplement: HesperidinCitrus peel extract |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects at risk for metabolic syndrome: a combination of 2 out of 5 components:
- Waist circumference: men > 102 cm / women > 88 cm
- Triglycerides: ≥ 1.7 mmol/l
- HDL-cholesterol: men ≤ 1.0 mmol/l / women ≤ 1.3 mmol/l
- Systolic blood pressure: ≥ 130 mmHg or diastolic blood pressure: ≥ 85 mmHg
Key exclusion criteria (17 listed)
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥7.0 mmol/l)
- Gastroenterological diseases or abdominal surgery
- Cardiovascular diseases, cancer, liver or kidney malfunction, thyroid disorders, disease with a life expectancy shorter than 5 years
- Self-admitted HIV-positive status
- Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
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 |
|---|---|---|
| HesperidinCitrus peel extract | Dietary supplement | Hesperidin |
| PlaceboCellulose | Dietary supplement | Placebo |
Primary outcome
Effect on blood glucose concentrations measured by oral glucose tolerance test
Time frame: 12 weeks
6 secondary outcomes
Effect on blood lipid profile
Time frame: 12 weeks
Effect on blood pressure
Time frame: 12 weeks
Effect on body composition measured by BMI
Time frame: 12 weeks
Effect on low-grade inflammation measured by blood concentration of TNFalfa
Time frame: 12 weeks
Effect on low-grade inflammation measured by blood concentration of interleukin-6
Time frame: 12 weeks
Effect on gut barrier function measured by a sugar test
Time frame: 12 weeks
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 20 Nov 2015.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Ad Masclee, MD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hesperidin in people with Metabolic Syndrome and Obesity, run by Maastricht University Medical Center 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 6 inclusion and 17 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 20 Nov 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect on blood glucose concentrations measured by oral glucose tolerance test (time frame: 12 weeks). 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 20 Nov 2015.