Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training

• ClinicalTrials.gov Identifier: NCT03523455
• Recruitment Status: Terminated
• First Posted: May 14, 2018
• Last Update Posted: August 8, 2018
• Sponsor: University of Mary Hardin-Baylor
• Collaborator: ChemiNutra
• Information provided by (Responsible Party): University of Mary Hardin-Baylor

Study Description

Brief Summary:

Participants are required to undergo a screening and qualification before beginning the study. Once qualified, baseline testing is completed in the laboratory. This testing includes: body composition measurements, a blood draw, questionnaires, a VO2 max test, and a time to exhaustion trial. This testing is repeated during week 4 and week 12. At week 8, subjects complete a blood draw and questionnaires only. During the 12 week period, participants will follow an endurance exercise program in which they will train 4 days per week. This is a double-blind study in which participants are randomized into either the placebo or supplement group. They are instructed to ingest the supplement once a day at breakfast. Diet logs are also monitored throughout the duration of the study with the restriction of no red meat.

Condition or disease	Intervention/treatment	Phase
Iron-deficiency	Dietary Supplement: Iron Aid IPS (Iron Protein Succinylate); Other: Sugar Pill	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two groups: placebo, 30mg dose
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: The Effects of Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training
• Actual Study Start Date: November 29, 2016
• Actual Primary Completion Date: November 11, 2017
• Actual Study Completion Date: November 11, 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Sugar Pill; Maltodextrin (matches the weight of the active treatment) Taken once each day after breakfast, but before lunch.	Other: Sugar Pill; 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.	Dietary Supplement: Iron Aid IPS (Iron Protein Succinylate); Taken orally in capsule form

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.
24. 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.
25. 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.
26. 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.
27. 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.
28. 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.
29. 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.
30. 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.
31. 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.
32. 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.
33. 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.
34. 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.
35. 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.
36. 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.
37. 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.
38. 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.
39. 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.
40. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: A female participant who is aerobically trained (have a minimum of 42 ml/kg/min), between the age of 18 and 30 years.
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. I am willing to and provide written and dated informed consent form to participate in the study;
2. I am female 18-30 years of age;
3. I am willing and able to comply with protocol;
4. My VO2 max is in compliance with age range (42 ml/kg/min);
5. I have not used or consumed any prescription drugs or supplements that could potentially confound the results of the current supplement;
6. I am apparently healthy and free from disease, as determined by a health history questionnaire;
7. I agree to abstain from strenuous activity and pre-workout supplementation 48 hours prior to each testing visit;
8. I must be fasted for 8 hours prior to each testing visit;
9. I agree to abstain from caffeine and alcohol consumption 24 hours prior to each testing visit;
10. I do not have any existing muscular disorders;
11. I am able to complete all testing on the 8th or 9th day after my menstrual cycle has ended.

Exclusion Criteria:

1. I use tobacco products or have quit within the past 6 months;
2. I am currently pregnant, plan on becoming pregnant, or become pregnant during the duration of the study;
3. I have given birth or been pregnant the past year;
4. I am currently taking or have taken any oral contraception within the past 6 months;
5. I have difficulty giving blood;
6. 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;
7. 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;
8. 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;
9. 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;
10. 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;
11. I have consumed any iron or mineral type dietary supplements (excluding multivitamins) 1 month prior to the study;
12. I have a history of food or drug allergy of any kind;
13. I have any other condition in which principal investigator thinks may jeopardize the study or the subject.

Contacts and Locations

Locations

United States, Texas

UMHB Human Performance Lab

Belton, Texas, United States, 76513

Sponsors and Collaborators

University of Mary Hardin-Baylor

ChemiNutra

Investigators

• Principal Investigator: Lemuel W Taylor, PhD; UMHB Human Performance Lab

More Information

• Responsible Party: University of Mary Hardin-Baylor
• ClinicalTrials.gov Identifier: NCT03523455
• Other Study ID Numbers: IRA-1
• First Posted: May 14, 2018
• Last Update Posted: August 8, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Mary Hardin-Baylor:

Iron; Exercise Performance; Fatigue

Additional relevant MeSH terms:

Fatigue; Iron protein succinylate; Hematinics