The Effect of AGE on the Immune System
कीवर्ड
सार
विवरण
Healthy, overweight adults age 25 to 65 will be recruited, consented and screened for eligibility. To assess for eligible study participants, the investigators will use the Cholestech LDX® System (Alere™ Inc, Waltham, MA) to analyze finger-prick blood samples. This is an efficient and economical point of care testing for c-Reactive Protein (CRP), cholesterol and related lipids, and blood glucose, as diagnostic tools which provide information for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and diabetes. Each finger prick will be treated individually. To this end, universal precautions such as hand washing, glove change, new lancet, etc. will be utilized for every finger prick throughout the assessment.
Eligible participants will be enrolled, and subsequently return, to provide a baseline blood draw, and given their random group assignment. Participants will be asked to consume three (3) capsules of 600 mg AGE or placebo with food twice a day, for a total of 3.6 grams per day. This dose was determined from previous studies that analyzed for cardiovascular risk factors. The supplementation (AGE and placebo) intervention will occur over 42 days, sometime between September 2013 and February 2013. Blood will be taken again at 42 days, two (2) hours after subjects have taken their capsules. A light breakfast will be offered after both fasting blood draws.
Peripheral blood mononuclear cells will be isolated from the blood at both blood draws and either used fresh, or cultured in autologous serum for 24 hours. Freshly isolated cells will be used to determine compliance (glutathione); population numbers of γδ T cells and monocytes and their function (activation); and mRNA expression of IL-6 and TNF-α. After 24 hours of stimulation with a broad based mitogen, culture medium will be harvested and assayed for IL-6, and TNF-α proteins. The cultured cells will be assayed for γδ T cell and monocyte function and for mRNA analysis of IL-6 and TNF-α gene expression. The serum obtained at both blood draws will be used in cultures as autologous serum and for assay of inflammatory biomarkers (C-reactive protein, IL-6, TNF-α, adiponectin and leptin). Compliance will also be determined by capsule count.
खजूर
| अंतिम सत्यापित: | 01/31/2016 |
| पहले प्रस्तुत किया गया: | 10/07/2013 |
| अनुमानित नामांकन प्रस्तुत किया गया: | 10/08/2013 |
| पहले पोस्ट किया गया: | 10/09/2013 |
| अंतिम अद्यतन प्रस्तुत किया: | 02/24/2016 |
| अंतिम अद्यतन पोस्ट: | 02/25/2016 |
| वास्तविक अध्ययन प्रारंभ दिनांक: | 12/31/2013 |
| अनुमानित प्राथमिक समापन तिथि: | 10/31/2015 |
| अनुमानित अध्ययन पूर्णता तिथि: | 10/31/2015 |
स्थिति या रोग
हस्तक्षेप / उपचार
Dietary Supplement: Aged Garlic Extract Supplementation
Other: Standard for Groups
Dietary Supplement: Placebo
चरण
शाखा समूह
| बांह | हस्तक्षेप / उपचार |
|---|---|
| Placebo Comparator: Placebo Placebo Group | Dietary Supplement: Placebo Participants will be asked to consume three (3) placebo capsules with food twice a day. |
| Experimental: Aged Garlic Extract Supplementation Aged Garlic Extract Supplementation Group | Dietary Supplement: Aged Garlic Extract Supplementation Subjects will be asked to consume three (3) capsules of 600 mg aged garlic extract (AGE) with food twice a day, for a total of 3.6 grams per day. |
पात्रता मापदंड
| युग अध्ययन के लिए पात्र | 25 Years सेवा 25 Years |
| सेक्स अध्ययन के लिए पात्र | All |
| स्वस्थ स्वयंसेवकों को स्वीकार करता है | हाँ |
| मानदंड | Inclusion Criteria: - ages 25-65 - BMI > or = to 30 kg/m2 - willing to discontinue dietary supplements - cRP between 2 and 10 mg/L Exclusion Criteria: - medication for hypertension, high cholesterol, heart failure, angina, etc - diagnoses of diabetes, metabolic syndrome, arthritis, severe allergies, or any other compromised immune condition - blood pressure > 135/85 mmHg - serum triglycerides > 150 mg/dl - HDL cholesterol < 40 mg/dl for men or < 50 mg/dl for women - fasting glucose > 110 mg/dl |
परिणाम
प्राथमिक परिणाम उपाय
1. Markers of immune health [6 weeks]
माध्यमिक परिणाम उपाय
1. Markers of inflammation [6 weeks]
अन्य परिणाम उपाय
1. Serum antioxidant status (compliance) [6 weeks]
