Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes in hemoglobin
Study Overview
Brief Summary
The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia. The investigators measured Improvement of Anemia parameters , including hemoglobin, transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Males and females 19-60 years old
- •Hemoglobin concentration less than 13g/dL(men), 12g/dL(women)
- •Able to give informed consent
Exclusion Criteria
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •Participation in any other clinical trials within past 2 months
- •History of alcohol or substance abuse
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •Pregnant or lactating women etc.
Arms & Interventions
Placebo
Intervention: Placebo (Dietary Supplement)
Heme-Iron
Intervention: Heme-Iron (Dietary Supplement)
Organic Iron
Intervention: Organic Iron (Dietary Supplement)
Heme-Iron Polypeptide
Intervention: Heme-Iron Polypeptide (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in hemoglobin
Time Frame: 4 weeks
Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week).
Changes in transferrin saturation
Time Frame: 4 weeks
Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week).
Secondary Outcomes
- Changes in serum iron(4 weeks)
- Changes in ferritin(4 weeks)
Investigators
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital