Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03589690
Status:
UNKNOWN
Last Update Posted:
2018-07-18
First Post:
2018-02-27
Brief Title:
Alpha Lipoic Acid Supplementation and Metabolic Syndrome
Sponsor:
Dr BAbbasi
Organization:
Science Research Islamic Azad University Branch Khozestan
Study Overview
Official Title:
Assessment of the Effect of Alpha Lipoic Acid Supplementation on Inflammatory Factors Insulin Resistance Glycemic Control and Anthropometric Indices in Patients With Metabolic Syndrome
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Metabolic syndrome is a collection of metabolic disorders Abdominal obesity dyslipidemia reduced levels of high-density lipoprotein cholesterol increased levels of serum triglyceride insulin resistance are among the risk factors for metabolic syndrome and it has a global prevalence of 10 - 50
Alpha-lipoic acid or thioctic acid is an antioxidant that may have effects on inflammatory pathways glucose control indicators blood pressure lipid profiles body weight fat mass and food intake regulation
This study will be conducted as a parallel randomized double-blind clinical trial In this study 44 patients will be enrolled from endocrine and metabolism center of Shariati Hospital where their metabolic syndrome was diagnosed by an endocrinologist At the beginning of the study written a self -administration will be taken from all patients
In this study patient will be randomly divided into two groups each will be received supplement or placebo for 12 weeks 22 of patients will be consume 600 mg Alpha lipoic acid for 12 weeks and 22 of patients will be consume 600 mg placebo starch-filled capsules daily Both supplementation and placebo are provided from Sepehr Drug and Treatment company Before the study containers will be coded as A and B by a person other than the study researchers according to concealment rules Physical activity information will be collected using short-IPAQ International Physical Activity Questionnaire and demographic information through a general information questionnaire In order to evaluate dietary intake of patients in terms of energykcalday carbohydrategrday proteingrday fat intakegrday SFA Saturated fatty acids grday MUFA Monounsaturated fatty acids grday PUFA Polyunsaturated fatty acidsgrday Vitamin Emgday Vitamin Cmgday Beta-carotenemgday and Sodium intake mgday 24-hr recalls will be completed by interviewing the patient for 3 days two normal days and a weekend day Weight will be measured with the minimum dress and without shoes by using a digital balance scale of 100 grams and height will be measured without shoes by meters mounted to the wall with an accuracy of 01 centimeters Then the body mass index will be calculated by dividing the weight kg by the square of the height m waist circumference will be measured in the narrowest area between the lowest lumbar spine and the iliac bone cm systolic and diastolic blood pressure will be measured after 15 minutes of rest twice using the mercuric barometric measure and the mean will be reported as individual blood pressure The blood sample will be taken after 12 hours of overnight fasting in two groups for measuring fasting blood glucosemgdL lipid profilemgdL glycosylated hemoglobinpercentage serum insulin concentration uIUml TAC Total antioxidant capacity umolL CRP C-reactive protein ngml and TNF-a Tumor necrosis factor-a pgmland will be used the HOMA-IR Homeostatic Model Assessment of Insulin Resistance formula to determine insulin resistance All these steps will be completed at the start and end of the study At the end of the study counting the remaining capsules the patients compliance rate will be evaluated and patients who have not consumed less than 90 of their capsules will be excluded from the analysis
Alpha-lipoic acid or thioctic acid is an antioxidant that may have effects on inflammatory pathways glucose control indicators blood pressure lipid profiles body weight fat mass and food intake regulation
This study will be conducted as a parallel randomized double-blind clinical trial In this study 44 patients will be enrolled from endocrine and metabolism center of Shariati Hospital where their metabolic syndrome was diagnosed by an endocrinologist At the beginning of the study written a self -administration will be taken from all patients
In this study patient will be randomly divided into two groups each will be received supplement or placebo for 12 weeks 22 of patients will be consume 600 mg Alpha lipoic acid for 12 weeks and 22 of patients will be consume 600 mg placebo starch-filled capsules daily Both supplementation and placebo are provided from Sepehr Drug and Treatment company Before the study containers will be coded as A and B by a person other than the study researchers according to concealment rules Physical activity information will be collected using short-IPAQ International Physical Activity Questionnaire and demographic information through a general information questionnaire In order to evaluate dietary intake of patients in terms of energykcalday carbohydrategrday proteingrday fat intakegrday SFA Saturated fatty acids grday MUFA Monounsaturated fatty acids grday PUFA Polyunsaturated fatty acidsgrday Vitamin Emgday Vitamin Cmgday Beta-carotenemgday and Sodium intake mgday 24-hr recalls will be completed by interviewing the patient for 3 days two normal days and a weekend day Weight will be measured with the minimum dress and without shoes by using a digital balance scale of 100 grams and height will be measured without shoes by meters mounted to the wall with an accuracy of 01 centimeters Then the body mass index will be calculated by dividing the weight kg by the square of the height m waist circumference will be measured in the narrowest area between the lowest lumbar spine and the iliac bone cm systolic and diastolic blood pressure will be measured after 15 minutes of rest twice using the mercuric barometric measure and the mean will be reported as individual blood pressure The blood sample will be taken after 12 hours of overnight fasting in two groups for measuring fasting blood glucosemgdL lipid profilemgdL glycosylated hemoglobinpercentage serum insulin concentration uIUml TAC Total antioxidant capacity umolL CRP C-reactive protein ngml and TNF-a Tumor necrosis factor-a pgmland will be used the HOMA-IR Homeostatic Model Assessment of Insulin Resistance formula to determine insulin resistance All these steps will be completed at the start and end of the study At the end of the study counting the remaining capsules the patients compliance rate will be evaluated and patients who have not consumed less than 90 of their capsules will be excluded from the analysis
Detailed Description:
This is a randomized double-blind parallel clinical trial of lipoic acid for inflammatory factors insulin resistance glycemic control and anthropometric indices in patients with metabolic syndrome patients are randomly shared into two groups and received 600 mg supplemental and placebo for 12 weeks Then the body mass index waist circumference systolic and diastolic blood pressure FBS fasting blood sugar lipid profile HbA1C serum insulin concentration TAC CRP and TNF-a Insulin resistance are measured All these steps will be done at the start and end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None