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

September 23, 2014 updated by: Gitte Jensen, Ph.D., Natural Immune Systems Inc

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

The purpose of this study is to evaluate the timing and magnitude of improvements to red blood cell health associated with consumption of Jobelyn™.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Klamath Falls, Oregon, United States, 97601
        • NIS Labs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo capsules
Placebo capsules
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
Sorghum bicolor leaf sheath extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin
Time Frame: 8 weeks
Change in hemoglobin levels
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting blood glucose
Time Frame: 8 weeks
Change in fasting glucose levels
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • NIS8914 (Other Grant/Funding Number: Health Forever Product Limited. Lagos, Nigeria)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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