Status:
COMPLETED
The Effects of a Multi-vitamin Supplement in Adult Females
Lead Sponsor:
Auburn University
Conditions:
Health, Subjective
Eligibility:
FEMALE
21-40 years
Phase:
NA
Brief Summary
The investigators are examining how the daily consumption of a multi-vitamin/mineral supplement affects the following variables in 21-40 year old women: 1. blood levels of various micronutrients (ass...
Detailed Description
The investigators are testing the efficacy of a multi-vitamin/mineral/omega-3 complex on psychological and physiological measures in pre-menopausal women (21-40 years old) over a 12-week period. This...
Eligibility Criteria
Inclusion
- Subjects must be healthy adult women (21-40 years)
- Subjects must possess a body mass index between 20-30 kg/m2
- Subjects can be of all demographics, race, and skin types
- Subjects must have a regular menstrual cycle
- Subjects must have never have smoked tobacco
- Subjects must be willing to practice at least one of the following methods of birth control: (1) Total abstinence from sexual intercourse with someone of the opposite sex during the study duration; (2) Sexual intercourse with a vasectomized partner; (3) Contraceptive (oral, parenteral, or transdermal) for at least 3 consecutive months prior to and during the study duration; (4) Use of an intrauterine contraceptive device; (5) Other acceptable forms of birth control (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
- Subjects must be able to travel to test site on scheduled dates/times without transportation issues.
Exclusion
- Any prescribed medication except for oral contraceptives (not acceptable if oral contraceptives are used to disrupt normal/monthly menstrual cycle) - includes recent antibiotic and/or oral corticosteroid use
- Medical history including the following: cardiovascular disease, cancer, coagulopathies, current anemia, epilepsy, thyroid disease, parathyroid diseases, diabetes, hepatitis, brain injuries or other brain-related diseases, depression treated with prescription medications, liver diseases, abnormal lipid metabolism, digestive disorders (Crohn's, pancreatitis, ulcerative colitis), multiple sclerosis, muscular dystrophy, asthma/COPD
- Anyone incapable of adhering to the study protocol or knowing likelihood of moving away from the study site
- Known allergies to algal oils, high-oleic sunflower oil, coconuts/coconut oil
- Pregnant (or become pregnant during the course of the study)
- Past or active smokers
- Irregular menstrual cycles or amenorrhea
- Donated blood within two months prior to study entry, and must not donate blood during the study duration
- Consumers of alcohol, \> 5 drinks of alcohol per week; one drink of alcohol was considered to be 142 mL of standard wine, 340 mL of beer, 35 mL of 80-proof liquor, or 10 mL of pure alcohol
- Dietary practices: more than one fish meal per week, or daily consumption of more than a Tablespoon of flaxseeds
- Caffeine-containing beverages are allowable if not excessive (more than the equivalent of 6 cups of coffee daily) and if they do not contain added vitamins; energy drinks or energy capsules containing caffeine are allowable if they have been used routinely
- Dietary Supplements: those taking multivitamin-mineral (MVM), prenatal vitamins, B vitamins, fish oil, krill oil, flaxseed oil dietary supplements. Meal replacement drinks or powders with 100% or more of the Daily Values for vitamins and minerals are also excluded, but if subjects cease their use they can be admitted into the study.
- \*Allowable supplements include calcium with or without Vitamin D (if the Vitamin D does not exceed 400 IU daily), fiber supplements not exceeding recommended doses on product labels, melatonin, niacin, herbal supplements without added vitamins, glucosamine/chondroitin, sports supplements, drinks or powders that do not contain vitamins and minerals (for example: protein powders, creatine, electrolytes, nitric oxide enhancers). Other supplements can be considered on a case-by-case basis.
- Study subjects must not be in active litigation regarding malpractice, workman's compensation, or disability claims.
- Study subjects must not be employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03828097
Start Date
May 1 2018
End Date
June 1 2019
Last Update
September 28 2020
Active Locations (1)
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1
School of Kinesiology, Auburn University
Auburn, Alabama, United States, 36849