NCT01828060

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™.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 10, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

April 2, 2013

Last Update Submit

September 23, 2014

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin

    Change in hemoglobin levels

    8 weeks

Secondary Outcomes (1)

  • Fasting blood glucose

    8 weeks

Study Arms (2)

Jobelyn™

EXPERIMENTAL

Dietary supplement Jobelyn™, 500mg daily for 8 weeks Jobelyn is a sorghum bicolor extract marketed as dietary supplement Other Name: Sorghum bicolor extract

Dietary Supplement: Jobelyn™

Placebo

PLACEBO COMPARATOR

Placebo capsules

Dietary Supplement: Placebo

Interventions

Jobelyn™DIETARY_SUPPLEMENT

Sorghum bicolor leaf sheath extract

Jobelyn™
PlaceboDIETARY_SUPPLEMENT

Placebo capsules

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

Location

Related Publications (6)

  • 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.

    PMID: 22489620BACKGROUND

  • 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.

    PMID: 21322653BACKGROUND

  • 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.

    PMID: 17890069BACKGROUND

  • 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.

    PMID: 17306481BACKGROUND

  • 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.

    PMID: 16039811BACKGROUND

  • 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.

    PMID: 23289787BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research director

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 10, 2013

Study Start

April 1, 2013

Primary Completion

August 1, 2013

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

US(1)