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difficulty to enroll more subjects
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| Name | Class |
|---|---|
| LycoRed Ltd. | INDUSTRY |
| The S. Daniel Abraham International Center for Health and Nutrition | OTHER |
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Effect of different doses of tomato extract (contain Lyc-o-Mato 6% Oleoresin which Contain: 5, 15 mg lycopene , in addition to Beta-carotene (0.15%), phytoene, and phytofluene (1%); and vitamin E (2%), phospholipids (15%), and phytosterols (0.6%) suspended in tomato oleoresin oil) compared with synthetic lycopene on blood pressure and plasma lycopene levels in never treated pre-hypertensive otherwise healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Active Comparator | Lyc-o-Mato 5mg |
|
| 3 | Active Comparator | Lyc-o-Mato 15mg |
|
| 4 | Active Comparator | Lyc-o-Mato 30mg |
|
| 5 | Active Comparator | Lycopene capsules (non Lyc-o-mato) 15 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyc-O-Mato 5mg | Dietary Supplement | Daily Lyc-O-Mato 5mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Every 2 weeks (Overall 12 weeks ) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum lycopene levels | Week 0,Week 12 | |
| Serum Phytofluene levels | Week 0,Week 12 | |
| Serum 8 isoprostane levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ester Paran, Professor | Hypertension clinic of the Soroka University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hypertension Unit | Beersheba | 84101 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16368299 | Background | Engelhard YN, Gazer B, Paran E. Natural antioxidants from tomato extract reduce blood pressure in patients with grade-1 hypertension: a double-blind, placebo-controlled pilot study. Am Heart J. 2006 Jan;151(1):100. doi: 10.1016/j.ahj.2005.05.008. |
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| Lyc-O-Mato 15mg | Dietary Supplement | Daily Lyc-O-Mato 15mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule |
|
| Lyc-O-Mato 30mg | Dietary Supplement | Daily Lyc-O-Mato 30mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule |
|
| Lycopene capsules (non Lyc-o-mato) 15 mg | Dietary Supplement | Daily Lycopene capsules (non Lyc-o-mato) 15 mg with lunch for 8 weeks (After 4 weeks of placebo run in). |
|
| Placebo | Other | Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks). |
|
| Week 0,Week 12 |
| Serum nitrite-nitrate levels | Week 0,Week 12 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077276 | Lycopene |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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