Lipoic Acid and Prevention of Heart Disease
کلید واژه ها
خلاصه
شرح
The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors such as body weight and high blood cholesterol levels in overweight or obese participants.
Recruitment will be in the Portland, Oregon area.
تاریخ
آخرین تأیید شده: | 02/29/2020 |
اولین ارسال: | 09/30/2008 |
ثبت نام تخمینی ارسال شد: | 09/30/2008 |
اولین ارسال: | 10/01/2008 |
آخرین بروزرسانی ارسال شده: | 03/01/2020 |
آخرین به روزرسانی ارسال شده: | 03/02/2020 |
تاریخ شروع مطالعه واقعی: | 03/31/2009 |
تاریخ تخمین اولیه اولیه: | 10/31/2011 |
تاریخ برآورد مطالعه: | 11/30/2020 |
شرایط یا بیماری
مداخله / درمان
Dietary Supplement: Lipoic Acid
Dietary Supplement: Placebo
فاز
گروههای بازو
بازو | مداخله / درمان |
---|---|
Active Comparator: Lipoic Acid 600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules) | Dietary Supplement: Lipoic Acid 600 mg in morning on empty stomach (two 300 mg capsules) |
Placebo Comparator: Placebo Placebo two caps every morning on empty stomach | Dietary Supplement: Placebo two capsules once daily in morning on empty stomach |
معیارهای صلاحیت
سنین واجد شرایط تحصیل | 18 Years به 18 Years |
جنسیت واجد شرایط مطالعه | All |
داوطلبان سالم را می پذیرد | آره |
شاخص | Inclusion Criteria: - Age 18-60 - Overweight (BMI, 25.0-29.9 kg/m2) or obese (BMI, >30 kg/m2); - Elevated plasma triglycerides (100-400 mg/dl); - Weight stable for the last three months and at lifetime maximum; - Exercise limited to 30 minutes 3 times a week or less; - Hs-CRP level at baseline of ≤ 10 mg/L; - Consuming ≤ 2 alcoholic drinks per day; Exclusion criteria: - Pregnant, breastfeeding, or planning to become pregnant before the end of the study. - Having had acute medical conditions, such as hospitalizations or surgeries, at least three months prior to entry into the study - Diagnosed as having diabetes (fasting glucose <125 mg/dl for entry), cardiovascular disease, congestive heart failure, angina, thyroid disorders, cancer, inflammatory disorders or renal, hepatic, or hematological abnormalities; - Currently taking lipid-lowering drugs, anti-hypertensive drugs, insulin , or oral hypoglycemic agents, anti-inflammatory drugs, weight loss medications, or hormone replacement therapy; - On an extreme diet and not maintaining a prudent diet; - Currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals; - Smoking within the last three months; |
نتیجه
اقدامات اولیه
1. Triglycerides [12 weeks and 24 weeks]
اقدامات ثانویه
1. Body weight and composition [12 and 24 weeks]
2. Markers of inflammation and oxidative stress [12 and 24 weeks]