Food Supplement for Individuals with Metabolic Syndrome

Not Applicable

Not yet recruiting

• Conditions: Metabolic Syndrome

• Registration Number: NCT06647108
• Lead Sponsor: ESI

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Study Start: 2025-01-10
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of the Dietary Supplement on Apo B	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).

Secondary Outcome Measures

Name	Time	Method
Effect of the Dietary Supplement on changes in body water	From enrollment to the end of treatment at 12 weeks	To evaluate the effect of the dietary supplement on changes in body water compared baseline and placebo after 12 weeks of treatment.
Effect of the Dietary Supplement on changes in lean body mass	From enrollment to the end of treatment at 12 weeks	To evaluate the effect of the dietary supplement on changes in lean body mass compared baseline and placebo after 12 weeks of treatment.
Effect of the Dietary Supplement on changes in fat body mass	From enrollment to the end of treatment at 12 weeks	To evaluate the effect of the dietary supplement on changes in fat body mass compared baseline and placebo after 12 weeks of treatment.
Effect of the Dietary Supplement on changes in waist circumference	From enrollment to the end of treatment at 12 weeks	To evaluate the effect of the dietary supplement on changes in waist circumference compared baseline and placebo after 12 weeks of treatment.
Dietary Supplement use and prevalence of Metabolic Syndrome	From enrollment to the end of treatment at 12 weeks	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.
Effect of the Dietary Supplement on changes in body water midway through the study	From enrollment to 6-week follow-up	To evaluate the effect of the dietary supplement on changes in body water compared baseline and placebo after 6 weeks of treatment
Effect of the Dietary Supplement on changes in lean body mass midway through the study	From enrollment to 6-week follow-up	To evaluate the effect of the dietary supplement on changes in lean body mass compared baseline and placebo after 6 weeks of treatment.
Effect of the Dietary Supplement on changes in fat body mass effect on cholesterol midway through the study	From enrollment to 6-week follow-up	To evaluate the effect of the dietary supplement on changes in fat body mass compared baseline and placebo after 6 weeks of treatment.
Effect of the Dietary Supplement on changes in waist circumference effect on cholesterol midway through the study	From enrollment to 6-week follow-up	To evaluate the effect of the dietary supplement on changes in waist circumference compared baseline and placebo after 6 weeks of treatment.

Trial Locations

Locations (1)

IRCCS AOU di Bologna; 🇮🇹 Bologna, Italy