Alpha Lipoic Acid Supplementation and Metabolic Syndrome

Assessment of the Effect of Alpha Lipoic Acid Supplementation on Inflammatory Factors, Insulin Resistance, Glycemic Control and Anthropometric Indices in Patients With Metabolic Syndrome

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 energy(kcal/(day), carbohydrate(gr/day), protein(gr/day), fat intake(gr/day), SFA (Saturated fatty acids) (gr/day), MUFA (Monounsaturated fatty acids) (gr/day), PUFA (Polyunsaturated fatty acids)(gr/day), Vitamin E(mg/day), Vitamin C(mg/day), Beta-carotene(mg/day) and Sodium intake (mg/day), 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 0.1 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 glucose(mg/dL), lipid profile(mg/dL), glycosylated hemoglobin(percentage), serum insulin concentration (uIU/ml) ,TAC (Total antioxidant capacity) (umol/L), CRP (C-reactive protein) (ng/ml) and TNF-a (Tumor necrosis factor-a ) (pg/ml)and 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 patient's compliance rate will be evaluated, and patients who have not consumed less than 90% of their capsules will be excluded from the analysis.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Alpha lipoic acid; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Behnood Abbasi, Ph.D.; Phone Number: 2522 44864929; Email: abbasi.b@srbiau.ac.ir
• Study Contact Backup: Name: Mahbubeh Ahmadi, M.Sc.; Phone Number: 09179611488; Email: ahmadimahbobe1396@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. having 3 criteria or more of the Metabolic Syndrome criteria presented in NCEP:ATP III (National Cholesterol Education Panel : Adult Treatment Panel III)
2. Adults(18-60 y)
3. PO (not fasting) and oral feeding ability
4. full person's willingness to cooperate in the project
5. Lack of digestive problems
6. Not pregnancy and Lactation
7. No history of myocardial infarction and brain stroke in the past year
8. Diabetes controlled
9. Lack of any Cardiovascular disease

Exclusion Criteria

1. Pregnancy
2. Cardiovascular and brain stroke
3. Diagnosis of uncontrolled diabetes during research
4. Have any need for medication that may interfere in the study process
5. Unwillingness to continue the cooperation of each research unit
6. Death of each research unit
7. Consume less than %90 of the number of supplement and placebo to be eaten
8. Involvement in other clinical trial in last three months
9. Menopause

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alpha Lipoic acid; Alpha lipoic acid capsules (600 mg/day)	Dietary supplement: Alpha lipoic acid; 22 Patients will consume 600 mg Alpha lipoic acid for 12 weeks .; Other Names: Thioctic acid , ALA (Alpha lipoic acid)
Placebo Comparator: Placebo; Starch-filled capsules (600 mg/day)	Dietary supplement: Placebo; Participants will be supplemented with 600 mg/day placebo (Starch).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of CRP	Serum C-reactive protein (ng/ml)	Baseline and 12 weeks after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of Tnf-a	Serum tumor necrosis factor-a (pg/ml)	Baseline and 12 weeks after
Change from baseline of FBS	Fasting blood glucose concentration (mg/dl)	Baseline and 12 weeks after
Change from baseline of Triglyceride	Serum TG (triacylglycerol) concentration (mg/dl)	Baseline and 12 weeks after
Change from baseline of total cholesterol	Serum TC (total cholesterol) concentration (mg/dl)	Baseline and 12 weeks after
Change from baseline of LDL-Cholesterol	Serum LDL concentration (mg/dl)	Baseline and 12 weeks after

Collaborators and Investigators

• Sponsor: Dr. B.Abbasi

Study record dates

Study Major Dates

• Study Start (Anticipated): July 25, 2018
• Primary Completion (Anticipated): April 25, 2019
• Study Completion (Anticipated): July 25, 2019

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: July 5, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Inflammation; Insulin Resistance; Metabolic Syndrome; Thioctic Acid
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Thioctic Acid
• Other Study ID Numbers: IR.IAU.SRB.REC.1396.82

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No