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The investigators are examining how the daily consumption of a multi-vitamin/mineral supplement affects the following variables in 21-40 year old women:
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:
Main outcome (dependent) variables between treatments will include:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental supplement | Experimental | Participants in this arm will receive two capsules per day containing a total of 1 mg boron, 600 mcg folate, 8 mg iron, 50 mg magnesium, 320 mg omega-3 (DHA+EPA), 8 mcg vitamin B12, 50 mcg vitamin D3, and 7 mg vitamin E |
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| Placebo | Placebo Comparator | Participants in this arm will receive two capsules per day containing safflower oil |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental supplement | Dietary Supplement | Subjects in both arms will consume two pills daily. Prior to and following 12 weeks of supplementation, participants will arrive to the laboratory following an overnight fast in order to donate blood as well as fill out EuroQoL and POMS questionnaires. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of micronutrients | Blood serum will be collected at PRE and POST-intervention and assessed for 25-hydroxycholecalciferol (25OHD), and folate as well as 6 associated metabolites [folic acid, 5-methyltetrahydrofolate (5-MeTHF), 5-formyltetrahydrofolate (5-FoTHF), homocysteine (Hcy), S-adenosylmethionine (SAM) and S-adenosylhomocysteine (SAH)]. Overall changes in these metabolites will be compared to pre-intervention values to determine if the experimental intervention was more effective at increasing one or multiple micronutrient levels in serum. | 12 weeks |
| Red blood cell omega-3 and omega-6 concentrations | Red blood cells will be collected at PRE and POST-intervention and assayed for red blood cell omega-3 and omega-6 fatty acid content. Overall changes in these metabolites will be compared to pre-intervention values to determine if the experimental intervention was more effective at altering these fatty acid levels in red blood cells. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood red blood cell concentrations | Whole blood will be collected at PRE and POST-intervention and assessed using a CBC test. The CBC test provides red concentration. Results from these tests will be compared to reference range values for apparently healthy female individuals. | 12 weeks |
| White blood cell concentrations |
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Inclusion Criteria:
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.
Individuals self-identifying as females will be eligible for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Kinesiology, Auburn University | Auburn | Alabama | 36849 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34327207 | Derived | Osburn SC, Roberson PA, Medler JA, Shake J, Arnold RD, Alamdari N, Bucci LR, Vance A, Sharafi M, Young KC, Roberts MD. Effects of 12-Week Multivitamin and Omega-3 Supplementation on Micronutrient Levels and Red Blood Cell Fatty Acids in Pre-menopausal Women. Front Nutr. 2021 Jul 13;8:610382. doi: 10.3389/fnut.2021.610382. eCollection 2021. |
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Double-blinded, parallel
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Pills are in white bottles with unique ID numbers (1-110). Pills are also flavor-matched (mint).
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| Placebo | Dietary Supplement | Subjects in both arms will consume two pills daily. Prior to and following 12 weeks of supplementation, participants will arrive to the laboratory following an overnight fast in order to donate blood as well as fill out EuroQoL and POMS questionnaires. |
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Whole blood will be collected at PRE and POST-intervention and assessed using a CBC test. The CBC test also provides white blood cell concentration. Results from these tests will be compared to reference range values for apparently healthy female individuals. |
| 12 weeks |
| Serum cholesterol concentrations | Whole blood will be collected at PRE and POST-intervention, and serum will be extracted and assessed using a chem-20 test. The chem-20 test provides serum lipid concentrations (i.e., LDL cholesterol, HDL cholesterol). Results from these tests will be compared to reference range values for apparently healthy female individuals. | 12 weeks |