The Effects of a Multi-vitamin Supplement on Mood and Blood Markers in Adult Females Prior to and Following 12 Weeks of Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Red blood cell omega-3 and omega-6 concentrations
研究概览
简要总结
The investigators are examining how the daily consumption of a multi-vitamin/mineral supplement affects the following variables in 21-40 year old women:
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Pills are in white bottles with unique ID numbers (1-110). Pills are also flavor-matched (mint).
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Red blood cell omega-3 and omega-6 concentrations
时间窗: 12 weeks
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.
Serum concentrations of micronutrients
时间窗: 12 weeks
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.
次要结局
- Blood red blood cell concentrations(12 weeks)
- White blood cell concentrations(12 weeks)
- Serum cholesterol concentrations(12 weeks)
研究者
Michael Roberts
Associate Professor
Auburn University