- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03523455
Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training
The Effects of Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects expressing interest in participating in this study, were interviewed in person to determine whether they appeared to qualify to participate in the study. If they met eligibility criteria, they were invited to attend an entry/familiarization session. During this session, they completed personal and medical histories which were reviewed to determine whether they met eligibility criteria. Once meeting entry criteria, they were familiarized to the study protocol via a verbal and written explanation outlining the study design. Subjects then read and signed the Informed Consent Statements after the study details were explained. Subjects then perform the exercise protocol in which they must have completed in order to qualify for the study.
Subjects were asked to perform a VO2 Max test using the Bruce protocol. Following the VO2 Max test, subjects were given a rest period of 20 minutes before starting the Time to Exhaustion (TTE) trial run. This session familiarized subjects with the exercise protocol preparing them for the qualification testing session. Subjects then returned to the lab in a 12 hour fasted state and completed a VO2max test. If a 42 ml/kg/min or above was achieved subjects were then allowed to complete the 20 minute TTE test. After completion of the TTE, a blood draw was done to access the subject's iron levels. Once results for iron levels returned at a 90 or below subjects were given an appointment time to perform baseline assessments and testing sessions.
Baseline testing (Week 0), Week 8 and Week 12 took place on the 8th or 9th day after the subject's menstrual cycle. Subjects returned to the lab in a 12 hour fasted state, with no strenuous workouts done 48 hours prior to testing. Subjects had their height and weight measured, filled out questionnaires, completed a DEXA scan and InBody to establish current body composition, afterwards having their heart rate and blood pressure assessed. At this point subjects were instructed to lay on a table for their blood draw. Once the blood draw was done, subjects completed a VO2 Max test using the Bruce protocol. Following the VO2 Max testing, subjects filled out 2 questionnaires and were given a rest period of 20 minutes before starting the Time to Exhaustion (TTE) trial run. During the rest period subjects were given a snack to ingest (banana or apple) and consumed the same snack at each testing session. Approximately 12 minutes prior to the TTE subjects filled out a questionnaire. During the TTE run subjects were able to control and see the speed at which they ran but were blinded to the time passed along with the distance completed. After the 20 minutes, the treadmill stopped, distance, heart rate and blood pressure were measured. Afterwards, subjects filled out post exercise questionnaires. At week 0, after all exercise testing was completed, subjects were assigned to a group (either placebo or active) and instructed to ingest 1 capsule per day. A workout log was also provided to each subject, who would return to the lab every Friday with their workout log to access exercise compliance.
At week 4, subjects returned to the lab on the 8th or 9th day after their menstrual cycle to have a blood draw completed to access blood marker variables in addition to questionnaires.
Diet logs were keep throughout the duration of the study and were monitored by lab staff.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Belton, Texas, United States, 76513
- UMHB Human Performance Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- I am willing to and provide written and dated informed consent form to participate in the study;
- I am female 18-30 years of age;
- I am willing and able to comply with protocol;
- My VO2 max is in compliance with age range (42 ml/kg/min);
- I have not used or consumed any prescription drugs or supplements that could potentially confound the results of the current supplement;
- I am apparently healthy and free from disease, as determined by a health history questionnaire;
- I agree to abstain from strenuous activity and pre-workout supplementation 48 hours prior to each testing visit;
- I must be fasted for 8 hours prior to each testing visit;
- I agree to abstain from caffeine and alcohol consumption 24 hours prior to each testing visit;
- I do not have any existing muscular disorders;
- I am able to complete all testing on the 8th or 9th day after my menstrual cycle has ended.
Exclusion Criteria:
- I use tobacco products or have quit within the past 6 months;
- I am currently pregnant, plan on becoming pregnant, or become pregnant during the duration of the study;
- I have given birth or been pregnant the past year;
- I am currently taking or have taken any oral contraception within the past 6 months;
- I have difficulty giving blood;
- I am currently diagnosed with having or currently involved in a managed treatment plan for any known metabolic disorder including heart disease, arrhythmias, diabetes, gall bladder, thyroid disease, or hypogonadism;
- I am diagnosed with having or are currently involved in a managed treatment plan for pulmonary disease, hypertension (defined as systolic blood pressure consistently greater than 140 mm Hg and/or a diastolic blood pressure greater than 90 mm Hg), hepatorenal disease, musculoskeletal disorders, neuromuscular/neurological diseases, autoimmune diseases, cancer, peptic ulcers, or anemia;
- I am medically prescribed by a physician to take or regularly take over the counter medications for any heart, pulmonary, thyroid, anti-hyperlipidemic, hypoglycemic, anti-hypertensive, endocrinologic (e.g. thyroid, insulin, etc.), neuromuscular/neurological, or androgenic medications due to possible further health hazards that could occur with diet alteration or exercise training;
- I report any unusual adverse events associated with this study that in consultation with the study investigators or supervision physician recommends removal from the study;
- I have taken ergogenic levels of nutritional supplements that may affect muscle mass or aerobic capacity (e.g., creatine, HMB) or anabolic/catabolic hormone levels (e.g., androstenedione, DHEA, etc.) within 6 months prior to the start of the study;
- I have consumed any iron or mineral type dietary supplements (excluding multivitamins) 1 month prior to the study;
- I have a history of food or drug allergy of any kind;
- I have any other condition in which principal investigator thinks may jeopardize the study or the subject.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Sugar Pill
Maltodextrin (matches the weight of the active treatment) Taken once each day after breakfast, but before lunch.
|
Taken orally in capsule form
|
ACTIVE_COMPARATOR: Iron Aid IPS (Iron Protein Succinylate)
IronAid Iron Protein Succinylate 30 mg Taken once each day after breakfast, but before lunch.
|
Taken orally in capsule form
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of IronAid IPS on Iron mcg/dL
Time Frame: 12 weeks (84 days)
|
The primary purpose is to observe the effect of supplementation on fasting total iron levels prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Ferritin ng/mL
Time Frame: 12 weeks (84 days)
|
The primary purpose is to observe the effect of supplementation on ferritin levels prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on the Exercise Induced Feeling Inventory
Time Frame: 12 weeks (84 days)
|
The primary purpose is to observe the effect of supplementation on feelings of fatigue prior to and after exercise testing in the laboratory at Week 0, 4, 12.
|
12 weeks (84 days)
|
Effect of IronAid IPS on the Rate of Perceived Exertion Scale
Time Frame: 12 weeks (84 days)
|
The primary purpose is to observe the effect of supplementation on feelings of fatigue after exercise testing in the laboratory at Week 0, 4, 12.
The scale ranges from 6 to 20 with 6 labeled as "no exertion" and 20 labeled as "maximal exertion".
All values are subjective and based on an individual's perception.
For the purposes of this study, a value ranged as close to 20 as possible to ensure maximal effort is achieved.
|
12 weeks (84 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of IronAid IPS on Glucose mg/dL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Urea Nitrogen (BUN) mg/Dl
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Creatinine mg/Dl
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on eGFR Non-Afr. American mL/min/1.73m2
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on eGFR African American mL/min/1.73m2
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on BUN/Creatinine Ratio calculated
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Sodium mmol/L
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Potassium mmol/L
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Chloride mmol/L
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Carbon Dioxide mmol/L
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Calcium mg/Dl
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Protein, Total g/Dl
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Albumin g/dL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Globulin g/Dl
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Albumin/Globulin Ratio calculated
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Bilirubin, Total mg/Dl
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Alkaline Phosphatase U/L
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Aspartate Aminotransferase U/L
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Alanine Aminotransferase U/L
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on White Blood Cell Count thousand/uL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Red Blood Cell Count million/uL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Hemoglobin g/dL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Hematocrit %
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on MCV fL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on MCH pg
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on MCHC g/dL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on RDW %
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Platelet Count thousand/uL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on MPV fL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Absolute Neutrophils cells/uL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Absolute Lymphocytes cells/uL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Absolute Monocytes cells/uL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Absolute Eosinophils cells/uL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Absolute Basophils cells/uL
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Neutrophils %
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Lymphocytes %
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Monocytes %
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Eosinophils %
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on Basophils %
Time Frame: 12 weeks (84 days)
|
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
|
12 weeks (84 days)
|
Effect of IronAid IPS on the Short form (36) Health Survey
Time Frame: Week 0, 4, 8, and 12
|
The secondary purpose is to assess the effects of ingesting the supplement on the immune system by means of completing this survey at Week 0, 4, 8 and 12.
|
Week 0, 4, 8, and 12
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRA-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Iron-deficiency
-
Pennington Biomedical Research CenterRecruitingIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
-
King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
-
Children's Hospital Los AngelesNot yet recruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
-
Swiss Federal Institute of TechnologyUnited States Agency for International Development (USAID); Quadram Institute... and other collaboratorsCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)Peru
-
Arrowhead Regional Medical CenterRecruitingIron Deficiency Anemia of PregnancyUnited States
-
Société des Produits Nestlé (SPN)CompletedIron-deficiency | Anemia | Iron Deficiency AnemiaPhilippines
-
Swiss Federal Institute of TechnologyUniversity of MalawiCompletedIron-deficiency | Iron Deficiency AnemiaMalawi, Switzerland
-
Johann Wolfgang Goethe University HospitalLudwig-Maximilians - University of MunichCompletedNon-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IXIron-deficiency | Anemia | Iron Deficiency AnemiaGermany
-
Kansas State UniversityUnited States Department of Agriculture Foreign Agricultural Service; American...CompletedIron-deficiency | Iron Deficiency AnemiaUnited States
-
Iowa State UniversityCompletedIron-deficiency | Bioavailability | Anemia, Iron Deficiency | Absorption; Iron | Serum IronUnited States
Clinical Trials on Sugar Pill
-
Massachusetts General HospitalGaneden Biotech, Inc.TerminatedIrritable Bowel Syndrome | Major Depressive DisorderUnited States
-
Harvard University Faculty of MedicineBeth Israel Deaconess Medical CenterCompletedIrritable Bowel SyndromeUnited States
-
Hospital de Clinicas de Porto AlegreCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... and other collaboratorsCompletedPeriampullary Carcinoma NosBrazil
-
GlaxoSmithKlineCompletedHealthy Subjects | Infections, BacterialAustralia
-
USDA Grand Forks Human Nutrition Research CenterCompletedInsomnia | Nutritional DeficiencyUnited States
-
Neurotune AGCross Research S.A.; Triclinium clinical trial project managment LTDCompletedNeuropathy | AIDSSouth Africa
-
Vantia LtdVeeda Clinical ResearchCompleted
-
University of California, Los AngelesCompletedAutism Spectrum DisorderUnited States
-
University of California, Los AngelesCompleted
-
Jiangsu Kanion Pharmaceutical Co., LtdBeijing Bionovo Medicine Development Co., Ltd.Completed