Alpha Lipoic Acid Supplementation and Metabolic Syndrome
Sleutelwoorden
Abstract
Omschrijving
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.
Datums
Laatst geverifieerd: | 06/30/2018 |
Eerste ingediend: | 02/26/2018 |
Geschatte inschrijving ingediend: | 07/04/2018 |
Eerst geplaatst: | 07/17/2018 |
Laatste update ingediend: | 07/04/2018 |
Laatste update geplaatst: | 07/17/2018 |
Werkelijke startdatum van het onderzoek: | 07/24/2018 |
Geschatte primaire voltooiingsdatum: | 04/24/2019 |
Geschatte voltooiingsdatum van het onderzoek: | 07/24/2019 |
Conditie of ziekte
Interventie / behandeling
Dietary Supplement: Alpha Lipoic acid
Dietary Supplement: Placebo
Fase
Armgroepen
Arm | Interventie / behandeling |
---|---|
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 . |
Placebo Comparator: Placebo Starch-filled capsules (600 mg/day) | Dietary Supplement: Placebo Participants will be supplemented with 600 mg/day placebo (Starch). |
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
Geslachten die in aanmerking komen voor studie | All |
Accepteert gezonde vrijwilligers | Ja |
Criteria | 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 |
Resultaat
Primaire uitkomstmaten
1. Change from Baseline of CRP [Baseline and 12 weeks after]
Secundaire uitkomstmaten
1. Change from baseline of Tnf-a [Baseline and 12 weeks after]
2. Change from baseline of FBS [Baseline and 12 weeks after]
3. Change from baseline of Triglyceride [Baseline and 12 weeks after]
4. Change from baseline of total cholesterol [Baseline and 12 weeks after]
5. Change from baseline of LDL-Cholesterol [Baseline and 12 weeks after]