Food Supplement for Individuals with Metabolic Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Food Supplement, Placebo.
- Who it may be relevant to
- Registry conditions: Metabolic Syndrome. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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:
1. increased waist circumference (WC) (as per population- and country-specific definition) 2. increased levels of triglycerides (TG) (≥ 150 mg/dL) 3. reduced high-density lipoprotein cholesterol (HDL-C) levels (\< 40 mg/dL in men and \< 50 mg/dL in women) 4. increased blood pressure (BP) (systolic BP≥ 130 mmHg and/or diastolic BP≥ 85 mmHg) 5. 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.
Interventions
- Dietary supplement Food 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 - Other Placebo
Placebo
Primary outcome measures
- Effect of the Dietary Supplement on Apo B [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- IRCCS AOU di Bologna — Bologna
Identifiers
NCT: NCT06647108 · MetaTreat_RCT2024