The Effects of a Multi-vitamin Supplement in Adult Females

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 study will be a double-blinded, placebo-controlled intervention. Briefly, subjects will be screened for inclusion criteria. Eligible subjects will then undergo a pre-testing battery (i.e., T1) and will then be randomly assigned to one of two groups including:

• Experimental group (anticipated n=50)
• Control group (anticipated n=50) Subjects will then consume 2 capsules per day for 12 weeks and perform a post-testing battery (i.e., T2) that includes tests performed during the pre-testing battery.

Main outcome (dependent) variables between treatments will include:

• blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays)
• blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)
• mood (assessed via questionnaires) Blood and questionnaires will be collected prior to supplementation, and 12 weeks into supplementation.

Statistics used to assess differences between conditions over time will include two-way repeated measures ANOVAs. When significant group*time interactions are observed, the statistical model will be decomposed using LSD post hoc tests.

Inclusion criteria

• 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 criteria

• 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.