The Effects of a Multi-vitamin Supplement in Adult Females

Not Applicable

Completed

• Conditions: Health, Subjective
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Experimental supplement

• Registration Number: NCT03828097
• Lead Sponsor: Auburn University

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 (assessed from blood draws using mass spectrometry-based assays)

2. blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)

3. mood (assessed via questionnaires) Blood and questionnaires will be collected prior to supplementation, and 12 weeks into supplementation.

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 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:

1. Experimental group (anticipated n=50)

2. 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:

1. blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays)

2. blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)

3. 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.

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

1. Subjects must be healthy adult women (21-40 years)
2. Subjects must possess a body mass index between 20-30 kg/m2
3. Subjects can be of all demographics, race, and skin types
4. Subjects must have a regular menstrual cycle
5. Subjects must have never have smoked tobacco
6. 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).
7. Subjects must be able to travel to test site on scheduled dates/times without transportation issues.

Exclusion Criteria

1. 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

2. 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

3. Anyone incapable of adhering to the study protocol or knowing likelihood of moving away from the study site

4. Known allergies to algal oils, high-oleic sunflower oil, coconuts/coconut oil

5. Pregnant (or become pregnant during the course of the study)

6. Past or active smokers

7. Irregular menstrual cycles or amenorrhea

8. Donated blood within two months prior to study entry, and must not donate blood during the study duration

9. 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

10. Dietary practices: more than one fish meal per week, or daily consumption of more than a Tablespoon of flaxseeds

11. 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

12. 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.

13. Study subjects must not be in active litigation regarding malpractice, workman's compensation, or disability claims.

14. Study subjects must not be employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants in this arm will receive two capsules per day containing safflower oil
Experimental supplement	Experimental supplement	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

Primary Outcome Measures

Name	Time	Method
Red blood cell omega-3 and omega-6 concentrations	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	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.

Secondary Outcome Measures

Name	Time	Method
Blood red blood cell concentrations	12 weeks	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.
White blood cell concentrations	12 weeks	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.
Serum cholesterol concentrations	12 weeks	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.

Trial Locations

Locations (1)

School of Kinesiology, Auburn University; 🇺🇸 Auburn, Alabama, United States