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| ID | Type | Description | Link |
|---|---|---|---|
| American River Nutrition | Other Identifier | ARN |
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| Name | Class |
|---|---|
| Texas Woman's University | OTHER |
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Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance for bone fractures. Women are 4 times more likely to have osteoporosis than men because there is no estrogen protection after menopause and women in general have lighter and thinner bones. Recent studies have indicated tocotrienols (one kind of vitamin E) supplement may be good for the bone health in postmenopausal women. However, no study has ever been done the role of tocotrienols in bone health in postmenopausal women. Our long-term goal is to develop a new strategy featuring a dietary supplement (i.e., tocotrienols) for slowing down bone loss in postmenopausal women. The purpose of the study is to examine the effect of 12-week tocotrienols on bone measurements in postmenopausal women. Investigators plan to recruit postmenopausal women using flyers, non-solicited e-mail system, campus announcement, local radio, newspapers, and TV scripts. We plan to enroll approximately 200 women to obtain 78 qualified women at the start of the study. After screening, qualified participants will be matched by body weight and age, and then randomly assigned to no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline, after 6, and after 12 weeks. Bone-related measurements will be recorded using blood and urine samples. Investigators will monitor safety of subjects after 6 and after 12 weeks. Food intake, physical activity, and quality of life will be assessed at baseline and 12 weeks. All data will be analyzed statistically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | No Intervention | No active dose of tocotrienols | |
| Low tocotrienols group | Active Comparator | Low dose of tocotrienols |
|
| High tocotrienols group | Active Comparator | High dose of tocotrienol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low tocotrienols group | Drug | 300 mg tocotrienols daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum bone resorption marker | serum C-terminal cross-linked telopeptide of type I collagen, CTX Change from baseline CTX at 12 weeks. Investigators will also assess change from baseline CTX at 6 weeks. | baseline and after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum bone formation marker | serum N-terminal propeptide of type I collagen, PINP | baseline, after 6 weeks, after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative stress marker | 8-hydroxy-2'-deoxyguanosine (8-OHdG) and urinary F2-isoprostanes (also called 8-iso-PGF2α) | baseline, after 6 weeks, after 12 weeks |
| Liver function test | serum aspartate aminotransferase (ALT) and alanine aminotransferase (AST) |
Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29954374 | Derived | Shen CL, Wang S, Yang S, Tomison MD, Abbasi M, Hao L, Scott S, Khan MS, Romero AW, Felton CK, Mo H. A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity, and nutrient intake. BMC Complement Altern Med. 2018 Jun 28;18(1):198. doi: 10.1186/s12906-018-2263-0. | |
| 29330573 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 22, 2024 | |
| Reset | Apr 17, 2024 | |
| Release | Jun 14, 2024 | |
| Reset | Jul 9, 2024 | |
| Release | Mar 27, 2025 | |
| Reset | Mar 27, 2025 | |
| Release | Sep 5, 2025 | |
| Reset | Sep 8, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 22, 2024 | Apr 17, 2024 | |||
| Jun 14, 2024 |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| High tocotrienols group |
| Drug |
600 mg tocotrienols daily |
|
| baseline, after 6 weeks, after 12 weeks |
| Quality of life Survey | SF-36 survey (v2) | baseline, after 6 weeks, after 12 weeks |
| Serum tocotrienols concentrations | baseline, after 6 weeks, after 12 weeks |
| Shen CL, Yang S, Tomison MD, Romero AW, Felton CK, Mo H. Tocotrienol supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women: a 12-week randomized double-blinded placebo-controlled trial. Osteoporos Int. 2018 Apr;29(4):881-891. doi: 10.1007/s00198-017-4356-x. Epub 2018 Jan 12. |
| 28011809 | Derived | Shen CL, Mo H, Yang S, Wang S, Felton CK, Tomison MD, Soelaiman IN. Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose-response double-blinded placebo-controlled randomised trial. BMJ Open. 2016 Dec 23;6(12):e012572. doi: 10.1136/bmjopen-2016-012572. |
| Jul 9, 2024 |
| Mar 27, 2025 | Mar 27, 2025 |
| Sep 5, 2025 | Sep 8, 2025 |
| D009750 |
| Nutritional and Metabolic Diseases |