Lipoic Acid and Prevention of Heart Disease
Parole chiave
Astratto
Descrizione
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.
Date
| Ultimo verificato: | 02/29/2020 |
| Primo inviato: | 09/30/2008 |
| Iscrizione stimata inviata: | 09/30/2008 |
| Primo pubblicato: | 10/01/2008 |
| Ultimo aggiornamento inviato: | 03/01/2020 |
| Ultimo aggiornamento pubblicato: | 03/02/2020 |
| Data di inizio effettiva dello studio: | 03/31/2009 |
| Data di completamento primaria stimata: | 10/31/2011 |
| Data stimata di completamento dello studio: | 11/30/2020 |
Condizione o malattia
Intervento / trattamento
Dietary Supplement: Lipoic Acid
Dietary Supplement: Placebo
Fase
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| 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 |
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | 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; |
Risultato
Misure di esito primarie
1. Triglycerides [12 weeks and 24 weeks]
Misure di esito secondarie
1. Body weight and composition [12 and 24 weeks]
2. Markers of inflammation and oxidative stress [12 and 24 weeks]
