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| ID | Type | Description | Link |
|---|---|---|---|
| NIS8914 | Other Grant/Funding Number | Health Forever Product Limited. Lagos, Nigeria |
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The purpose of this study is to evaluate the timing and magnitude of improvements to red blood cell health associated with consumption of Jobelynâ„¢.
From past history, case studies in Nigeria, as well as testimonials from all over the world, have shown a robust increase in hemoglobin within a few weeks in people with serious cases of anemia present under disease conditions such as sickle cell, Malaria, HIV, or cancer. In parallel, improvements in red blood cell health were also seen in many healthy people with general low blood counts due to undetermined factors.
A clinical study on anemia is currently ongoing in Nigeria. The study population is focused on women and aims at evaluating whether Jobelynâ„¢ consumption can help increase hemoglobin and thus reduce risk factors associated with gynecological surgery in a Nigerian cohort of gynecological patients (ClinicalTrials.gov Identifier: NCT01670955).
As a parallel to the ongoing study in Nigeria, this study protocol will help to systematically examine the effects of Jobelynâ„¢ on anemic conditions in an otherwise healthy North American population, and help document the speed and magnitude of improvements in a population without concomitant infections or sickle cell anemia.
Twenty-four human subjects of both genders will be tested over a period of 8 weeks. Both genders may enroll in the study, but we expect more women to be eligible, due to effects of menses and prolonged consumption of birth control pills. Recruiting of volunteers will happen via NIS Labs. A screening blood draw will be used for CBC/differential and the hemoglobin level help determine eligibility.
Enrolled subjects will randomized to consume placebo or Jobelynâ„¢ for 8 weeks, during which time subjects are monitored at baseline, and after 3 days, 7 days, and 2, 4, and 8 weeks. A fasting blood sample will be taken at each visit, and used for hemoglobin and fasting glucose measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jobelynâ„¢ | Experimental | Dietary supplement Jobelynâ„¢, 500mg daily for 8 weeks Jobelyn is a sorghum bicolor extract marketed as dietary supplement Other Name: Sorghum bicolor extract |
|
| Placebo | Placebo Comparator | Placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jobelynâ„¢ | Dietary Supplement | Sorghum bicolor leaf sheath extract |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Change in hemoglobin levels | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood glucose | Change in fasting glucose levels | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Klamath Falls | Oregon | 97601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22489620 | Background | Geera B, Ojwang LO, Awika JM. New highly stable dimeric 3-deoxyanthocyanidin pigments from sorghum bicolor leaf sheath. J Food Sci. 2012 May;77(5):C566-72. doi: 10.1111/j.1750-3841.2012.02668.x. Epub 2012 Apr 10. | |
| 21322653 | Background | Kayode AP, Nout MJ, Linnemann AR, Hounhouigan JD, Berghofer E, Siebenhandl-Ehn S. Uncommonly high levels of 3-deoxyanthocyanidins and antioxidant capacity in the leaf sheaths of dye sorghum. J Agric Food Chem. 2011 Feb 23;59(4):1178-84. doi: 10.1021/jf103963t. Epub 2011 Jan 25. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Placebo |
| Dietary Supplement |
Placebo capsules |
|
| 17890069 | Background | Camargo Filho I, Cortez DA, Ueda-Nakamura T, Nakamura CV, Dias Filho BP. Antiviral activity and mode of action of a peptide isolated from Sorghum bicolor. Phytomedicine. 2008 Mar;15(3):202-8. doi: 10.1016/j.phymed.2007.07.059. Epub 2007 Sep 24. |
| 17306481 | Background | Oladiji AT, Jacob TO, Yakubu MT. Anti-anaemic potentials of aqueous extract of Sorghum bicolor (L.) moench stem bark in rats. J Ethnopharmacol. 2007 May 22;111(3):651-6. doi: 10.1016/j.jep.2007.01.013. Epub 2007 Jan 18. |
| 16039811 | Background | Falade OS, Otemuyiwa IO, Oladipo A, Oyedapo OO, Akinpelu BA, Adewusi SR. The chemical composition and membrane stability activity of some herbs used in local therapy for anemia. J Ethnopharmacol. 2005 Oct 31;102(1):15-22. doi: 10.1016/j.jep.2005.04.034. |
| 23289787 | Background | Benson KF, Beaman JL, Ou B, Okubena A, Okubena O, Jensen GS. West African Sorghum bicolor leaf sheaths have anti-inflammatory and immune-modulating properties in vitro. J Med Food. 2013 Mar;16(3):230-8. doi: 10.1089/jmf.2012.0214. Epub 2013 Jan 5. |