Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training
Status: | Terminated |
---|---|
Conditions: | Anemia |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - 30 |
Updated: | 8/10/2018 |
Start Date: | November 29, 2016 |
End Date: | November 11, 2017 |
The Effects of Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training
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.
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.
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.
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.
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.
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