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

NCT03523455 | Terminated

• 1 other identifier: IRA-1
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-deficiency

Keywords

Iron; Exercise Performance; Fatigue

Outcome Measures

Primary Outcomes (4)

• Effect of IronAid IPS on Iron mcg/dL

  The primary purpose is to observe the effect of supplementation on fasting total iron levels prior to and after the supplementation period.

  12 weeks (84 days)

• Effect of IronAid IPS on Ferritin ng/mL

  The primary purpose is to observe the effect of supplementation on ferritin levels prior to and after the supplementation period.

  12 weeks (84 days)

• Effect of IronAid IPS on the Exercise Induced Feeling Inventory

  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.

  12 weeks (84 days)

• Effect of IronAid IPS on the Rate of Perceived Exertion Scale

  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.

  12 weeks (84 days)

Secondary Outcomes (40)

• Effect of IronAid IPS on Glucose mg/dL

  12 weeks (84 days)

• Effect of IronAid IPS on Urea Nitrogen (BUN) mg/Dl

  12 weeks (84 days)

• Effect of IronAid IPS on Creatinine mg/Dl

  12 weeks (84 days)

• Effect of IronAid IPS on eGFR Non-Afr. American mL/min/1.73m2

  12 weeks (84 days)

• Effect of IronAid IPS on eGFR African American mL/min/1.73m2

  12 weeks (84 days)

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Maltodextrin (matches the weight of the active treatment) Taken once each day after breakfast, but before lunch.

Other: Sugar Pill

Iron Aid IPS (Iron Protein Succinylate)

ACTIVE COMPARATOR

IronAid Iron Protein Succinylate 30 mg Taken once each day after breakfast, but before lunch.

Dietary Supplement: Iron Aid IPS (Iron Protein Succinylate)

Interventions

Iron Aid IPS (Iron Protein Succinylate) DIETARY_SUPPLEMENT

Taken orally in capsule form

Iron Aid IPS (Iron Protein Succinylate)

Sugar Pill OTHER

Taken orally in capsule form

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: A female participant who is aerobically trained (have a minimum of 42 ml/kg/min), between the age of 18 and 30 years.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of Mary Hardin-Baylor: lead
• ChemiNutra: collaborator

Study Sites (1)

UMHB Human Performance Lab

Belton, Texas, 76513, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Fatigue

Interventions

iron protein succinylate; Sugars

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Lemuel W Taylor, PhD

  UMHB Human Performance Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups: placebo, 30mg dose

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: November 29, 2016
• Primary Completion: November 11, 2017
• Study Completion: November 11, 2017
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

US (1)