Clinical trial NCT03523455: Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training
Official title: The Effects of Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Iron-deficiency
Keywords: Iron
Exercise Performance
Fatigue
Lead sponsor: University of Mary Hardin-Baylor
Sponsor class: OTHER
Collaborators: name: ChemiNutra
First posted: 2018-05-14
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: placebo, 30mg dose
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Effect of IronAid IPS on Iron mcg/dL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Ferritin ng/mL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on the Exercise Induced Feeling Inventory
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on the Rate of Perceived Exertion Scale
timeFrame: 12 weeks (84 days)
Secondary outcomes:
measure: Effect of IronAid IPS on Glucose mg/dL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Urea Nitrogen (BUN) mg/Dl
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Creatinine mg/Dl
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on eGFR Non-Afr. American mL/min/1.73m2
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on eGFR African American mL/min/1.73m2
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on BUN/Creatinine Ratio calculated
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Sodium mmol/L
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Potassium mmol/L
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Chloride mmol/L
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Carbon Dioxide mmol/L
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Calcium mg/Dl
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Protein, Total g/Dl
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Albumin g/dL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Globulin g/Dl
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Albumin/Globulin Ratio calculated
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Bilirubin, Total mg/Dl
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Alkaline Phosphatase U/L
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Aspartate Aminotransferase U/L
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Alanine Aminotransferase U/L
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on White Blood Cell Count thousand/uL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Red Blood Cell Count million/uL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Hemoglobin g/dL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Hematocrit %
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on MCV fL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on MCH pg
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on MCHC g/dL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on RDW %
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Platelet Count thousand/uL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on MPV fL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Absolute Neutrophils cells/uL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Absolute Lymphocytes cells/uL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Absolute Monocytes cells/uL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Absolute Eosinophils cells/uL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Absolute Basophils cells/uL
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Neutrophils %
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Lymphocytes %
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Monocytes %
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Eosinophils %
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on Basophils %
timeFrame: 12 weeks (84 days)
measure: Effect of IronAid IPS on the Short form (36) Health Survey
timeFrame: Week 0, 4, 8, and 12
Other outcomes:
Locations:
city: Belton
country: United States
facility: UMHB Human Performance Lab
state: Texas
Study officials:
affiliation: UMHB Human Performance Lab
name: Lemuel W Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References: