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Efficacy of Jobelyn™ Consumption on Hemoglobin Levels in a Borderline Anemic Population

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ClinicalTrials.gov Identifier: NCT01828060
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : September 25, 2014
Information provided by (Responsible Party):
Gitte Jensen, Ph.D., Natural Immune Systems Inc

Tracking Information
First Submitted Date  ICMJE April 2, 2013
First Posted Date  ICMJE April 10, 2013
Last Update Posted Date September 25, 2014
Study Start Date  ICMJE April 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
Hemoglobin [ Time Frame: 8 weeks ]
Change in hemoglobin levels
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
Fasting blood glucose [ Time Frame: 8 weeks ]
Change in fasting glucose levels
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy of Jobelyn™ Consumption on Hemoglobin Levels in a Borderline Anemic Population
Official Title  ICMJE Efficacy of Jobelyn™ Consumption on Hemoglobin Levels in a Borderline Anemic Population.
Brief Summary The purpose of this study is to evaluate the timing and magnitude of improvements to red blood cell health associated with consumption of Jobelyn™.
Detailed Description

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 Jobelyn™ 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 Jobelyn™ 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 Jobelyn™ 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Condition  ICMJE Anemia
Intervention  ICMJE
  • Dietary Supplement: Jobelyn™
    Sorghum bicolor leaf sheath extract
  • Dietary Supplement: Placebo
    Placebo capsules
Study Arms  ICMJE
  • Experimental: Jobelyn™
    Dietary supplement Jobelyn™, 500mg daily for 8 weeks Jobelyn is a sorghum bicolor extract marketed as dietary supplement Other Name: Sorghum bicolor extract
    Intervention: Dietary Supplement: Jobelyn™
  • Placebo Comparator: Placebo
    Placebo capsules
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2014)
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2013)
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-65 year old people of either gender
  • Borderline anemic (This is compensated for altitude of study location):
  • Hemoglobin level at or below 13.5 g/dL(women)
  • Hemoglobin level at or below 15.5 g/dL(men)

Exclusion Criteria:

  • Known diagnosis with pernicious or other megaloblastic anemias, aplastic, sickle cell, thalassemia, autoimmune hemolytic anemias;
  • Known diagnosis with Hashimoto's Disease;
  • Known chronic kidney disease;
  • Rheumatoid arthritis;
  • Splenectomy;
  • Serious active illness within past 12 months;
  • Active cancer and/or chemotherapy within the last 12 months;
  • Major surgery during past 8 weeks;
  • Scheduled surgery during study;
  • Received blood transfusion during the past 8 weeks;
  • Having donated blood for 6 weeks prior to study, or planning to donate blood during the 8 week study;
  • Distance athlete;
  • Unable to commit to staying on a constant regimen of medication and supplements for the duration of the study, with the exception of changes to medication needed for optimal care;
  • Changes to prescription medication within 2 weeks before starting the study;
  • Participation in other clinical trials during the month before this study begins;
  • Participating in other clinical trials during this study;
  • Current use of any dietary supplements that may affect hemoglobin levels; Vitamin B12 (over 500 mcg), Iron (over 100mg), or any other dietary supplement that, in the opinion of the investigator, may affect hemoglobin levels;
  • Currently experiencing intense stressful events/ life changes that would negatively affect compliance;
  • Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery is not a problem, including appendix and gallbladder removal);
  • Females of child-bearing potential: Pregnant, nursing, or trying to become pregnant;
  • Food allergies related to sorghum or rice.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01828060
Other Study ID Numbers  ICMJE NIS8914
NIS8914 ( Other Grant/Funding Number: Health Forever Product Limited. Lagos, Nigeria )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gitte Jensen, Ph.D., Natural Immune Systems Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Natural Immune Systems Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Natural Immune Systems Inc
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP