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To investigate the effect of a supplement capsule containing LRCâ„¢ (L. reuteri NCIMB 30242), taken twice daily with lunch and dinner (NLT 2.5E9 CFU per dose), versus placebo capsule on serum low density lipoprotein (LDL)-cholesterol in otherwise healthy hypercholesterolemic adults after 9 weeks of product consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LRCâ„¢ capsule | Experimental |
| |
| Placebo capsule | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LRCâ„¢ capsule | Dietary Supplement | Twice per day (BID), 9 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum LDL-cholesterol after 9 weeks of product consumption. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum LDL-cholesterol after 6 weeks of product consumption. | 6 weeks | |
| Serum total cholesterol after 6 and 9 weeks of product consumption. | 6 and 9 weeks | |
| Serum HDL-cholesterol after 6 and 9 weeks of product consumption. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo capsule |
| Other |
Twice per day (BID), 9 weeks |
|
| 6 and 9 weeks |
| Serum non-HDL-cholesterol after 6 and 9 weeks of product consumption. | 6 and 9 weeks |
| Serum triglycerides after 6 and 9 weeks of product consumption. | 6 and 9 weeks |
| Serum apolipoprotein B-100 after 6 and 9 weeks of product consumption. | 6 and 9 weeks |
| Serum hs-CRP after 9 weeks of product consumption. | 9 weeks |
| Plasma fibrinogen after 9 weeks of product consumption. | 9 weeks |
| Plasma homocysteine after 9 weeks of product consumption. | 9 weeks |
| GI health questionnaire score after 6 and 9 weeks of product consumption. | 6 and 9 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |