None listed
Conditions
Brief summary
Whilst the importance of diet on health and well-being has long been established, there has been a recent interest in the effects of nutritional status on mood and memory. For instance, deficiencies in a number of nutrients have been associated with poorer mood. For this reason researchers have focused on the role of vitamins and minerals including folate, vitamins B12, B6 and zinc in the treatment of mood and stress disorders, as well as a way to improve cognition (i.e. memory, attention, mental function), general well-being and quality of life. Previous research studies have shown that taking a multivitamin for at least one month may improve the mood, general well-being and cognition of middle aged and older adults. This study will investigate the effects of a Women’s 50+ multivitamin supplement on mood, cognition and well-being.
Interventions
In this study participants will supplement their diet with one multivitamin, (or placebo) supplement each day for
30 days. The investigational product will be the Swisse Women’s 50+ Ultivite. The multivitamin is available
over the counter in Australian supermarkets and chemists.
Participants will be given a tablet log to mark off each day, once they have taken their supplement. All remaining tablets, along with the log, will be returned at the end of the supplementation period to monitor compli
In this study participants will supplement their diet with one multivitamin, (or placebo) supplement each day for 30 days. The investigational product will be the Swisse Women’s 50+ Ultivite. The multivitamin is available over the counter in Australian supermarkets and chemists. Participants will be given a tablet log to mark off each day, once they have taken their supplement. All remaining tablets, along with the log, will be returned at the end of the supplementation period to monitor compliance. EACH MULTIVITAMIN TABLET CONTAINS: Vitamin A 2500 IU (retinyl acetate 750 mcg RE)Vitamin E 24.2 IU (d-alpha tocopheryl acid succinate 20 mg) Vitamin D3 200 IU (cholecalciferol 5 mcg) Vitamin B1 (thiamine hydrochloride 30 mg) Vitamin B2 (riboflavin 30 mg) Nicotinamide 20 mg Vitamin B5 (pantothenic acid 64.13 mg from calcium pantothenate 70 mg) Vitamin B6 (pyridoxine 24.68 mg from pyridoxine hydrochloride 30 mg) Vitamin B12 (cyanocobalamin 115 mcg) Biotin 150 mcg Folic acid 500 mcg Vitamin K (phytomenadione 60 mcg) Vitamin C (ascorbic acid 165.3 mg from calcium ascorbate dihydrate 200 mg) Citrus bioflavonoids extract 20 mg Calcium 10 mg (calcium orotate 100 mg) Magnesium 7.5 mg (magnesium aspartate dihydrate 100 mg) Selenium 26 mcg (selenomethionine 65 mcg) Molybdenum 45 mcg (molybdenum trioxide 67.5 mcg) Chromium 50 mcg (chromium picolinate 402mcg) Manganese 3 mg (manganese amino acid chelate 30 mg) Iron 5 mg (ferrous fumarate 16.01 mg) Copper 1.2 mg (copper gluconate 8.57 mg) Zinc 15 mg (zinc amino acid chelate 75 mg) Iodine 149.83 mcg (potassium iodide 196 mcg) Silicon 9.35 mg (silica colloidal anhydrous 20 mg) Lecithin powder – soy phosphatidylserine enriched soy 10 mg (phosphatidylserine 2 mg) Co-enzyme Q10 (ubidecarenone 2 mg) Spearmint oil 2 mg Lutein 1 mg EXTRACTS EQUIVALENT TO DRY: Skullcap 50 mg (Scutellaria lateriflora herb) Nettle 100 mg (Urtica dioica leaf) Black cohosh 200 mg (Cimicifuga racemosa root & rhizome) Withania 500 mg (Withania somnifera root) Damiana 500 mg (Turnera diffusa leaf) Hawthorn 100 mg (Crataegus monogyna fruit) EXTRACTS EQUIVALENT TO FRESH: Cranberry 800 mg (Vaccinium macrocarpon fruit) Globe artichoke 50 mg (Cynara scolymus leaf) STANDARDISED EXTRACTS EQUIVALENT TO: Brahmi 50 mg (Bacopa monnieri whole plant dry) Grape seed 1.0 g (Vitis vinifera seed dry) Ginkgo 1.0 g (Ginkgo biloba leaf dry) St. Mary’s thistle 1.5 g (Silybum marianum fruit dry) Turmeric 100 mg (Curcuma longa rhizome dry) Bilberry 100 mg (Vaccinium myrtillus fruit fresh)
Sponsors
Swinburne University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female 2. Aged 50 - 75 years 3. Not currently working fulltime 4. Non-smokers 5. English speaking 6. Free from other medical conditions which may affect ability to participate in the study.
Exclusion criteria
1. Smoker 2. History of diabetes or cardiovascular disease 3. History of epilepsy or Parkinson’s disease. 4. History of anxiety, depression, or psychiatric disorders. 5. History of dementia, stroke and other neurological conditions, head trauma. 6. MMSE score less than 25/30 7. Alcohol abuse past/present. 8. Use of, vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St John’s Wort or other cognitive enhancing dietary or herbal supplement in the 4 weeks preceding the baseline study visit. 9. Not willing to abstain from using vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St John’s Wort, or other cognitive enhancing dietary or herbal supplements over the study period. 10. Taking the following: high dose anti-coagulant drugs (Warfarin, Heparin, Plavix); anti-cholinergics or acetylcholinesterase inhibitors: bethanechol (Ureholine), donepezil (Aricept), rivastigmine (Exelon), galantamine (Reminyl), edrophonium (Enoln, Reversol, Tensilon), neostigmine (Prostigmin). 11. Use of anti-depressant medications such as Sertraline (Zoloft), paroxetine (Paxil), fluoxetine (Prozac) or any other antidepressant medication. 12. Taking anti-anxiety medication such as diazepam (Valium), alprazolam (Xanax).
Outcome results
None listed