Clinical trial NCT01828060: Efficacy of Jobelyn™ Consumption on Hemoglobin Levels in a Borderline Anemic Population
Official title: Efficacy of Jobelyn™ Consumption on Hemoglobin Levels in a Borderline Anemic Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anemia
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin
timeFrame: 8 weeks
Secondary outcomes:
measure: Fasting blood glucose
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Klamath Falls
country: United States
facility: NIS Labs
state: Oregon
Study officials:
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