Metabolic SyndromeMETA-TREATNCT06647108
Food Supplement for Individuals with Metabolic Syndrome
A study testing Food Supplement in people with Metabolic Syndrome, run by ESI at 1 site in Italy.
Trial summary
In metabolic syndrome, blood levels of apolipoprotein B (Apo B) reveal the presence of quantitative and qualitative alterations of atherogenic lipoproteins and therefore represent an indicator of the risk of developing cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Food Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 years and ≤ 70 years old;
- Subjects with metabolic syndrome (according to the IAS criteria);
- Subjects with an estimated 10-year risk of CVD< 10% (as per the SCORE risk prediction algorithm of the ESC)
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements;
- Subjects agree to participate in the study and having dated and signed the informed consent form
Who cannot join
- Treatment with lipid-lowering drugs or taking food supplements that are effective on blood lipid levels;
- Chronic pharmacological treatments for any clinical condition not stabilized for at least 3 months;
- Known alterations in thyroid, renal or hepatic function (including transaminase values ≥ 3 times the times the upper limit of the normal range (ULN));
- Present or previous alcohol abuse;
- Pregnancy and breastfeeding;
- Subjects with known intolerance to one of the components of the tested dietary supplement;
- History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS AOU di Bologna
Bologna, Bologna, 40100
Arrigo Francesco Giuseppe Cicero, MD, PhD, +39 051 214290, arrigo.cicero@unibo.it
Marina Giovannini, BD
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effect of a Food Supplement on Apolipoprotein B in Individuals with Metabolic Syndrome Adhering to the Mediterranean Diet
In metabolic syndrome, blood levels of apolipoprotein B (Apo B) reveal the presence of quantitative and qualitative alterations of atherogenic lipoproteins and therefore represent an indicator of the risk of developing cardiovascular disease (CVD). The objective of this study is to evaluate the effect of a combined dietary supplement containing glucomannan, white mulberry dry extract (d.e.), gymnema (d.e.), olive (d.e.), Cassia nomame (d.e.), Nopal, policosanols and chromium, compared to placebo, on Apo B in individuals with metabolic syndrome adhering to the Mediterranean diet. Furthermore, the effect of the dietary supplement on anthropometric parameters, waist circumference and body composition will be investigated.
Read the detailed description
Metabolic syndrome is a highly prevalent condition characterized by the simultaneous presence of multiple cardiometabolic risk factors, such as arterial hypertension, atherogenic dyslipidemia, hyperglycemia and abdominal obesity. According to the International Atherosclerosis Society (IAS), metabolic syndrome is a clustering of at least three of the following five medical conditions:
- increased waist circumference (WC) (as per population- and country-specific definition)
- increased levels of triglycerides (TG) (≥ 150 mg/dL)
- reduced high-density lipoprotein cholesterol (HDL-C) levels (< 40 mg/dL in men and < 50 mg/dL in women)
- increased blood pressure (BP) (systolic BP≥ 130 mmHg and/or diastolic BP≥ 85 mmHg)
- impaired fasting glucose [fasting plasma glucose (FPG)≥ 100 mg/dL] In metabolic syndrome, blood levels of apolipoprotein B (Apo B) reveal the presence of quantitative and qualitative alterations of atherogenic lipoproteins and therefore represent an indicator of the risk of developing cardiovascular disease (CVD).
Troubling increases in high FPG, high body mass index (BMI), and other risk factors related to obesity and metabolic syndrome indicate an urgent need to identify and implement interventions, as shown by the Global Burden of Disease (GBD) Study Group. To date, several active ingredients of natural origin have been shown to favorably modify the individual components that have revealed the presence of metabolic syndrome. Among these, we find glucomannan and white mulberry dry extract.
The purpose of this study is to evaluate if a dietary supplement containing glucomannan, white mulberry dry extract (d.e.), gymnema (d.e.), olive (d.e.), Cassia nomame (d.e.), Nopal, policosanols and chromium, is able to significantly influence serum levels of apo B in individuals with metabolic syndrome adhering to the Mediterranean diet. Furthermore, the effect of the dietary supplement on anthropometric parameters, waist circumference and body composition will be investigated.
- Conditions
- Metabolic Syndrome
- Being tested
- Food Supplement, Placebo
- Keywords
- Metabolic Syndrome, Apolipoprotein B, Dietary Supplement, Food Supplement, Mediterranean Diet, Body Composition
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food SupplementDietary supplement
The composition of the dietary supplement is the following (for 1 sachet): 450 mg glucomannan, 250 mg white mulberry dry extract (d.e.), 200 mg gymnema (d.e.), 200 mg olive (d.e.), 200 mg Cassia nomame (d.e.), 200 mg Nopal, 5 mg policosanols and 20 µg chromium
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Food Supplement | Active comparator | The composition of the dietary supplement is the following (for 1 sachet): 450 mg glucomannan, 250 mg white mulberry dry extract (d.e.), 200 mg gymnema (d.e.), 200 mg olive (d.e.), 200 mg Cassia nomame (d.e.), 200 mg Nopal, 5 mg policosanols and 20 µg chromium. Receives: Dietary Supplement: Food Supplement |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the Dietary Supplement on Apo B
The primary objective is to compare the effect on Apo B after 12 weeks of treatment with the dietary supplement or placebo, in combination with the Mediterranean diet (Standard of Care - SOC).
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (9)
Effect of the Dietary Supplement on changes in body water
To evaluate the effect of the dietary supplement on changes in body water compared baseline and placebo after 12 weeks of treatment.
Measured: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in lean body mass
To evaluate the effect of the dietary supplement on changes in lean body mass compared baseline and placebo after 12 weeks of treatment.
Measured: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in fat body mass
To evaluate the effect of the dietary supplement on changes in fat body mass compared baseline and placebo after 12 weeks of treatment.
Measured: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in waist circumference
To evaluate the effect of the dietary supplement on changes in waist circumference compared baseline and placebo after 12 weeks of treatment.
Measured: From enrollment to the end of treatment at 12 weeks
Dietary Supplement use and prevalence of Metabolic Syndrome
To verify whether the intake of the dietary supplement is associated with a reduction in the prevalence of metabolic syndrome, compared to baseline and compared to placebo, after 12 weeks of treatment.
Measured: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in body water midway through the study
To evaluate the effect of the dietary supplement on changes in body water compared baseline and placebo after 6 weeks of treatment
Measured: From enrollment to 6-week follow-up
Effect of the Dietary Supplement on changes in lean body mass midway through the study
To evaluate the effect of the dietary supplement on changes in lean body mass compared baseline and placebo after 6 weeks of treatment.
Measured: From enrollment to 6-week follow-up
Effect of the Dietary Supplement on changes in fat body mass effect on cholesterol midway through the study
To evaluate the effect of the dietary supplement on changes in fat body mass compared baseline and placebo after 6 weeks of treatment.
Measured: From enrollment to 6-week follow-up
Effect of the Dietary Supplement on changes in waist circumference effect on cholesterol midway through the study
To evaluate the effect of the dietary supplement on changes in waist circumference compared baseline and placebo after 6 weeks of treatment.
Measured: From enrollment to 6-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start10 Jan 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ESI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arrigo Francesco Giuseppe Cicero, MD, PhD, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647108
- Sponsor's protocol ID
- MetaTreat_RCT2024
- Acronym
- META-TREAT
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 17 Oct 2024
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effect of a Food Supplement on Apolipoprotein B in Individuals with Metabolic Syndrome Adhering to the Mediterranean Diet
- ClinicalTrials.gov ID
- NCT06647108
- Acronym / sponsor ID
- META-TREAT / MetaTreat_RCT2024
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Apolipoprotein B, Dietary Supplement, Food Supplement, Mediterranean Diet, Body Composition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ESIIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Oct 2024 (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.
In metabolic syndrome, blood levels of apolipoprotein B (Apo B) reveal the presence of quantitative and qualitative alterations of atherogenic lipoproteins and therefore represent an indicator of the risk of developing cardiovascular disease (CVD). The objective of this study is to evaluate the effect of a combined dietary supplement containing glucomannan, white mulberry dry extract (d.e.), gymnema (d.e.), olive (d.e.), Cassia nomame (d.e.), Nopal, policosanols and chromium, compared to placebo, on Apo B in individuals with metabolic syndrome adhering to the Mediterranean diet. Furthermore, the effect of the dietary supplement on anthropometric parameters, waist circumference and body composition will be investigated.
Detailed description
Metabolic syndrome is a highly prevalent condition characterized by the simultaneous presence of multiple cardiometabolic risk factors, such as arterial hypertension, atherogenic dyslipidemia, hyperglycemia and abdominal obesity. According to the International Atherosclerosis Society (IAS), metabolic syndrome is a clustering of at least three of the following five medical conditions:
- increased waist circumference (WC) (as per population- and country-specific definition)
- increased levels of triglycerides (TG) (≥ 150 mg/dL)
- reduced high-density lipoprotein cholesterol (HDL-C) levels (< 40 mg/dL in men and < 50 mg/dL in women)
- increased blood pressure (BP) (systolic BP≥ 130 mmHg and/or diastolic BP≥ 85 mmHg)
- impaired fasting glucose [fasting plasma glucose (FPG)≥ 100 mg/dL] In metabolic syndrome, blood levels of apolipoprotein B (Apo B) reveal the presence of quantitative and qualitative alterations of atherogenic lipoproteins and therefore represent an indicator of the risk of developing cardiovascular disease (CVD).
Troubling increases in high FPG, high body mass index (BMI), and other risk factors related to obesity and metabolic syndrome indicate an urgent need to identify and implement interventions, as shown by the Global Burden of Disease (GBD) Study Group. To date, several active ingredients of natural origin have been shown to favorably modify the individual components that have revealed the presence of metabolic syndrome. Among these, we find glucomannan and white mulberry dry extract.
The purpose of this study is to evaluate if a dietary supplement containing glucomannan, white mulberry dry extract (d.e.), gymnema (d.e.), olive (d.e.), Cassia nomame (d.e.), Nopal, policosanols and chromium, is able to significantly influence serum levels of apo B in individuals with metabolic syndrome adhering to the Mediterranean diet. Furthermore, the effect of the dietary supplement on anthropometric parameters, waist circumference and body composition will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food Supplement | Active comparator | Dietary Supplement: Food SupplementThe composition of the dietary supplement is the following (for 1 sachet): 450 mg glucomannan, 250 mg white mulberry dry extract (d.e.), 200 mg gymnema (d.e.), 200 mg olive (d.e.), 200 mg Cassia nomame (d.e.), 200 mg Nopal, 5 mg policosanols and 20 µg chromium. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged ≥ 18 years and ≤ 70 years old;
- Subjects with metabolic syndrome (according to the IAS criteria);
- Subjects with an estimated 10-year risk of CVD< 10% (as per the SCORE risk prediction algorithm of the ESC)
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements;
- Subjects agree to participate in the study and having dated and signed the informed consent form
Key exclusion criteria (7 listed)
- Treatment with lipid-lowering drugs or taking food supplements that are effective on blood lipid levels;
- Chronic pharmacological treatments for any clinical condition not stabilized for at least 3 months;
- Known alterations in thyroid, renal or hepatic function (including transaminase values ≥ 3 times the times the upper limit of the normal range (ULN));
- Present or previous alcohol abuse;
- Pregnancy and breastfeeding;
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 |
|---|---|---|
| Food SupplementThe composition of the dietary supplement is the following (for 1 sachet): 450 mg glucomannan, 250 mg white mulberry dry extract (d.e.), 200 mg gymnema (d.e.), 200 mg olive (d.e.), 200 mg Cassia nomame (d.e.), 200 mg Nopal, 5 mg policosanols and 20 µg chromium | Dietary supplement | Food Supplement |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Effect of the Dietary Supplement on Apo B
Time frame: From enrollment to the end of treatment at 12 weeks
The primary objective is to compare the effect on Apo B after 12 weeks of treatment with the dietary supplement or placebo, in combination with the Mediterranean diet (Standard of Care - SOC).
9 secondary outcomes
Effect of the Dietary Supplement on changes in body water
Time frame: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in lean body mass
Time frame: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in fat body mass
Time frame: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in waist circumference
Time frame: From enrollment to the end of treatment at 12 weeks
Dietary Supplement use and prevalence of Metabolic Syndrome
Time frame: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in body water midway through the study
Time frame: From enrollment to 6-week follow-up
Effect of the Dietary Supplement on changes in lean body mass midway through the study
Time frame: From enrollment to 6-week follow-up
Effect of the Dietary Supplement on changes in fat body mass effect on cholesterol midway through the study
Time frame: From enrollment to 6-week follow-up
Effect of the Dietary Supplement on changes in waist circumference effect on cholesterol midway through the study
Time frame: From enrollment to 6-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- 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.
Arrigo Francesco Giuseppe Cicero, MD, PhD principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Supplement in people with Metabolic Syndrome, run by ESI at 1 site in Italy.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Oct 2024. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arrigo Francesco Giuseppe Cicero, MD, PhD (+39 051 214290, arrigo.cicero@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the Dietary Supplement on Apo B (time frame: From enrollment to the end of treatment at 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 17 Oct 2024.