Clinical trial NCT06647108: Food Supplement for Individuals with Metabolic Syndrome
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Apolipoprotein B
Dietary Supplement
Food Supplement
Mediterranean Diet
Body Composition
Lead sponsor: ESI
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.

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.

Primary outcomes:
measure: Effect of the Dietary Supplement on Apo B
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Effect of the Dietary Supplement on changes in body water
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Effect of the Dietary Supplement on changes in lean body mass
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Effect of the Dietary Supplement on changes in fat body mass
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Effect of the Dietary Supplement on changes in waist circumference
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Dietary Supplement use and prevalence of Metabolic Syndrome
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Effect of the Dietary Supplement on changes in body water midway through the study
timeFrame: From enrollment to 6-week follow-up
measure: Effect of the Dietary Supplement on changes in lean body mass midway through the study
timeFrame: From enrollment to 6-week follow-up
measure: Effect of the Dietary Supplement on changes in fat body mass effect on cholesterol midway through the study
timeFrame: From enrollment to 6-week follow-up
measure: Effect of the Dietary Supplement on changes in waist circumference effect on cholesterol midway through the study
timeFrame: From enrollment to 6-week follow-up
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna
Study officials:
affiliation: University of Bologna
name: Arrigo Francesco Giuseppe Cicero, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: