Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
Schlüsselwörter
Abstrakt
Beschreibung
Inclusion Criteria
- Calcium scan with Agatston score >20
- Age 35-84 years
- Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
- Subjects should be stable on their concomitant medications for at least 12 weeks prior to randomization
- Subjects who agree to refrain from supplemental garlic or significant dietary garlic
Exclusion Criteria
- A contraindication to Aged Garlic Extract therapy including: known hypersensitivity to drug.
- Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
- Weight in excess of 325 pounds
- Bleeding disorder
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
- Resting hypotension (a resting systolic blood pressure of <90 mm Hg) or hypertension (a resting blood pressure > 170 mm Hg or a resting diastolic blood pressure of >110 mm Hg)
- NYHA Class III or IV heart failure
- History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
- Serum creatinine > 1.4 mg/dl
- Triglycerides > 400 at visit 1
- Diabetic subjects with HbA1c > 12%
- Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
- Concurrent enrollment in another placebo-controlled trial
- Presence of metal clips (i.e. bypass patients) or intracoronary stenting that preclude accurate measure of coronary calcification
- Partial ileal bypass or known gastrointestinal disease limiting drug absorption
- Current intake of garlic supplement or other prohibited drug (Appendix B)
- Current tobacco use
- Current use of anticoagulants (except for antiplatelet agents)
- Chronic renal failure
- Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
Outcome Measures Primary - Rate of change in total coronary calcium scores by CT The Agatston score was calculated by multiplying the lesion area (mm^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater.
Secondary Change in blood values and endothelial function over 6 and 12 months:
1. Plasma lipids: total plasma cholesterol and triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol determined by the precipitation method;
2. Endothelial markers and inflammation: C-reactive protein and Homocysteine, as well as GSH
Termine
| Zuletzt überprüft: | 01/31/2015 |
| Zuerst eingereicht: | 03/10/2009 |
| Geschätzte Einschreibung eingereicht: | 03/10/2009 |
| Zuerst veröffentlicht: | 03/11/2009 |
| Letztes eingereichtes Update: | 02/27/2015 |
| Letztes Update veröffentlicht: | 03/11/2015 |
| Datum der ersten eingereichten Ergebnisse: | 01/26/2013 |
| Datum der ersten eingereichten QC-Ergebnisse: | 02/27/2015 |
| Datum der ersten veröffentlichten Ergebnisse: | 03/11/2015 |
| Tatsächliches Startdatum der Studie: | 04/30/2009 |
| Geschätztes primäres Abschlussdatum: | 07/31/2010 |
| Voraussichtliches Abschlussdatum der Studie: | 08/31/2010 |
Zustand oder Krankheit
Intervention / Behandlung
Dietary Supplement: Aged Garlic Extract and Coenzyme Q10
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Active Comparator: Aged Garlic Extract and Coenzyme Q10 AGE (1200 mg) and CoQ10 (120 mg)
This is a combination of aged garlic extract and co-enzyme Q10 | Dietary Supplement: Aged Garlic Extract and Coenzyme Q10 AGE (1200 mg) and CoQ10 (120 mg) |
| No Intervention: Placebo placebo pills will be given |
Zulassungskriterien
| Altersberechtigt für das Studium | 35 Years Zu 35 Years |
| Studienberechtigte Geschlechter | Male |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | Inclusion Criteria: - Calcium scan with Agatston score >20 - Age 35-84 years - Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them - Subjects should be stable on their concomitant medications for at least 12 weeks prior to randomization - Subjects who agree to refrain from supplemental garlic or significant dietary garlic Exclusion Criteria: - A contraindication to Aged Garlic Extract therapy including: known hypersensitivity to drug. - Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study - Weight in excess of 325 pounds - Bleeding disorder - History of myocardial infarction, stroke or life-threatening arrhythmia within the prior six months - Resting hypotension (a resting systolic blood pressure of <90 mm Hg) or hypertension (a resting blood pressure > 170 mm Hg or a resting diastolic blood pressure of >110 mm Hg) - NYHA Class III or IV heart failure - History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy - Serum creatinine > 1.4 mg/dl - Triglycerides > 400 at visit 1 - Diabetic subjects with HbA1c > 12% - Drug or alcohol abuse, or current intake of more than 14 standard drinks per week - Concurrent enrollment in another placebo-controlled trial - Presence of metal clips (i.e. bypass patients) or intracoronary stenting that preclude accurate measure of coronary calcification - Partial ileal bypass or known gastrointestinal disease limiting drug absorption - Current intake of garlic supplement or other prohibited drug (Appendix B) - Current tobacco use - Current use of anticoagulants (except for antiplatelet agents) - Chronic renal failure - Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI |
Ergebnis
Primäre Ergebnismaße
1. Rate of Change in Total Coronary Calcium Scores by Computed Tomography [1 year]
Sekundäre Ergebnismaße
1. 1.Plasma Lipids: Total Plasma Cholesterol and Triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol Determined by the Precipitation Method; 2. Endothelial Markers and Inflammation: C-reactive Protein and Homocysteine, as Well as GSH [1 year]
