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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Iron-deficiency

In brief

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.

Key facts

Study ID

NCT03523455

Run by

University of Mary Hardin-Baylor

People needed

2

Starts

2016-11-29

Expected to finish

2017-11-11

Last updated by the study team

2018-08-08

Who can join

Age: 18 and older, up to 30. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UMHB Human Performance Lab — Belton, Texas, United States

Full record on ClinicalTrials.gov

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