None listed
Conditions
Brief summary
Multivitamin supplements have been reported to be the most commonly taken dietary supplements in Australia (Australian Bureau of Statistics., (2020-21). Supplement users were also found to have higher intakes, in their diet (from food only), of fibre and more vitamins and minerals (except zinc and vitamin B12) than non-supplement users. Additionally, intakes of all vitamins and minerals were higher when the contribution from supplements was added into overall intakes. This demonstrates the potential benefits of multivitamins to supplement overall nutrient levels, with the aim of supporting overall health and wellbeing (Burnett et al., 2017). To best support the health and wellbeing of Australians, Swisse conducted a targeted reformulation of their Ultivite Multivitamins to ensure that they were meeting the present needs of Australian adults as evidenced in the population data. This real-world direct-to-participant study aims to understand healthy volunteers’ perspectives and experiences whilst taking the Swisse Ultivite Multivitamin products. Presently, the rigorous clinical trials and scientific evidence that is used to support relevant indications, in line with TGA requirements and approval, does not reflect a real-world environment. Research of this nature is not intended for regulatory submission/dossier nor for pack claims, but rather seeks to explore typical product use and understanding of participant perspective in an environment that is not tightly controlled. In order to replicate a real-world setting, the use of randomization, blinding and placebo is not included, and the limitations of the study design have been greatly considered. Overall, the study aims to generate complementary evidence on user experiences for Swisse Ultivite Multivitamins for the purpose of publication and potential use in advertising claims.
Interventions
This study involves the testing for 4 weeks of a regulatory-approved multivitamin supplement which is available in the market. It has been specifically tailored for the nutritional needs of different genders and age groups.
Males - 18-50yo: Swisse Ultivite Men’s Multivitamin
Females - 10-50yo: Ultivite Women’s Multivitamin
Males - 51+yo: Swisse Ultivite Men’s 50+ Multivitamin
Females -51+yo: Swisse Ultivite Women’s 50+ Multivitamin
Each participant was placed with one Multivitamin bottle based
This study involves the testing for 4 weeks of a regulatory-approved multivitamin supplement which is available in the market. It has been specifically tailored for the nutritional needs of different genders and age groups. Males - 18-50yo: Swisse Ultivite Men’s Multivitamin Females - 10-50yo: Ultivite Women’s Multivitamin Males - 51+yo: Swisse Ultivite Men’s 50+ Multivitamin Females -51+yo: Swisse Ultivite Women’s 50+ Multivitamin Each participant was placed with one Multivitamin bottle based on their age & gender. The product has been manufactured to the highest of standards, has undergone quality assessments and is listed by the Therapeutics Goods Administration (TGA) for safety and quality. The products are TGA-listed Swisse Ultivite Women’s Multivitamin (ARTG Entry: 380720), Swisse Ultivite Men’s Multivitamin (ARTG Entry: 380723), Swisse Ultivite Women’s 50+ Multivitamin (ARTG Entry: 380936), Swisse Ultivite Men’s 50+ Multivitamin (ARTG Entry: 380937), The use post-marketing of the products is as per label. Dosage: 1 tablet daily for 4 weeks. Mode of Administration: Oral Product Ingredients List as per label: • Artificial Flavours • Biotin • Egg • Folic Acid • Nicotinamide • Vitamin - B1, B2, B5, B6, B12, C, D3, E • Minerals - Calcium, Iodine • Chromium • Copper • Potassium • Iron • Lactose • Magnesium • Manganese • Potassium • Selenium • Zinc • Betacarotene • Choline • Co-enzyme Q10 • Egg • Inositol • Lutein • Lysine • Spearmint Oil • Astragalus • Bilberry • Celery • Fennel • Ginger • Ginkgo • Globe Artichoke • Gluten • Grape Seed • Gotu Kola • Green Tea • Korean Ginseng • Liquorice • Milk Thistle • Papaya • Parsley • Saw Palmetto • Soya beans • Tomato • Yeast
Sponsors
Swisse Wellness Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must meet all inclusion criteria in order to be eligible to participate in the study: 1. Consent to participate in the research, collect data, receive product for trial. 2. Aged between 18 and 65 years, both inclusive. 3. Good general health based on a self-reported absence of any chronic health condition or co-morbidities and the absence of any medication relating to such conditions (e.g. diabetes, etc.). The only allowed medication is contraceptives. For the 18-50yo group, participants taking medication for hypertension and hypercholesterolemia will also be included. Note: Stable medically managed hypertension (HTN) or hypercholesterolaemia is a stable and chronically managed condition. It is unlikely to cause any significant interference with trial primary or secondary outcomes. 4. Body mass index (BMI) lower than 35 kg/m2 5. Female subjects of child-bearing potential are eligible if: • currently using the same reliable hormonal contraceptive method (oral contraceptive, implant, intra-uterine device, patch, vaginal ring, or injection) for at least 2 months prior to study inclusion and throughout the study or • currently using a reliable non-hormonal contraceptive method (copper intra-uterine device, condoms, diaphragm, cervical cap or spermicide) for every occasion or are surgically sterile (oophorectomy, hysterectomy or tubal ligation) or • agree not to have unprotected sexual intercourse throughout the study duration. 6. Individuals who agree to continue their “usual” exercise routine for the duration of the study.
Exclusion criteria
Participants meeting any of the following criteria will not be eligible to participate in the study: 1. Individuals with medical conditions (absolute contraindications): narcolepsy, chronic fatigue, long covid, depression, heart failure, renal impairment, liver impairment (ASA 1 patients). 2. Individuals with identified nutritional deficiencies, particularly iron and B12. 3. Individuals currently taking any other herbal supplements (however, participants as such who cease usage 1 month prior to study commencement can be included) – Applicable to 51-65yo group. 4. Individuals who are pregnant and/or lactating, or who are planning to become pregnant during the study or four weeks after the study 5. Individuals who are currently taking any other supplement (e.g., (multi)vitamins, minerals, omega-3 fatty acids (EPA, DHA, ALA), fibre, herbal.) - Applicable to 51-65yo group. 6. Individuals currently taking any supplements like Multivitamins, B vitamins, and/or any other supplements (vitamins/minerals or herbals) that target physical energy and/or mental stamina. Patients who are long term (>4weeks) stable supplement therapy, where the supplement is not known to have any interaction, is unlikely to have any effect on primary or secondary outcomes. Stable therapy forms part of their baseline where the trial will essentially measure the deviation from this baseline. (Also, participants as such who cease usage 2 weeks prior to study commencement can be included). - Applicable to 18-50yo group. 7. Individuals with known or suspected intolerance or hypersensitivity to the product ingredients (or closely related compounds) or any of their stated ingredients. 8. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit. 9. Individuals categorised as an elite athlete by their National Sporting Organisation (NSO) or another relevant athletic organisation. 10. Individuals who use substances (i.e., alcohol, cannabis, hallucinogens, cocaine, opioids, and sedatives) 11. Individuals who do not agree to limit their alcohol consumption as per the Australian guidelines (i.e., no more than 10 standard drinks a week and no more than 4 standard drinks on any one day) during the study period. 12. Personnel: I. An employee of the sponsor or the study site or members of their immediate family II. A person who is engaged in the production, marketing or supply of the goods (a relevant person); III. A person who is engaged in the marketing or supply of therapeutic goods includes influencers, direct sellers and other persons who have, or will receive, valuable consideration for making the testimonial. IV. A member of a relevant person’s immediate family, unless the advertisement discloses that the person who made the testimonial is an immediate family member of the relevant person; V. Employees or contractors of a government or government authority, a hospital, or healthcare facility, other than a community pharmacy; VI. A current or former health practitioner, health professional or medical researcher; VII. A person who represents themselves as being qualified or trained to diagnose, treat or prevent disease, ailment, defect or injury in persons. Please note, V, VI & VII are applicable to 51-65yo group participants only. For the 18-50yo group, these exclusions have been relaxed to facilitate recruitment. These changes are representative of the Australian population/real world setting, and have been checked with the Medical Monitor and the TGA. Please note this exclusion should not have any impact on the study data.'
Outcome results
None listed