Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647108
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Food Supplement for Individuals with Metabolic Syndrome
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
META-TREAT
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 de gymnema de olive de Cassia nomame de 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 mgdL
3 reduced high-density lipoprotein cholesterol HDL-C levels 40 mgdL in men and 50 mgdL in women
4 increased blood pressure BP systolic BP 130 mmHg andor diastolic BP 85 mmHg
5 impaired fasting glucose fasting plasma glucose FPG 100 mgdL 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 de gymnema de olive de Cassia nomame de 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
1 increased waist circumference WC as per population- and country-specific definition
2 increased levels of triglycerides TG 150 mgdL
3 reduced high-density lipoprotein cholesterol HDL-C levels 40 mgdL in men and 50 mgdL in women
4 increased blood pressure BP systolic BP 130 mmHg andor diastolic BP 85 mmHg
5 impaired fasting glucose fasting plasma glucose FPG 100 mgdL 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 de gymnema de olive de Cassia nomame de 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None