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

Iron-deficiency Clinical Trial

Official title: The Effects of Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Fatigue
• Iron-deficiency

• NCT number: NCT03523455
• Study type: Interventional
• Source: University of Mary Hardin-Baylor
• Status: Terminated
• Phase: N/A
• Start date: November 29, 2016
• Completion date: November 11, 2017