Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001081606
Ethics application status
Approved
Date submitted
25/07/2023
Date registered
11/10/2023
Date last updated
11/10/2023
Date data sharing statement initially provided
11/10/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Project ULTI: Evaluating the end-user experience of the reformulated Ultivite and Ultivite 50 plus Multivitamins on energy, fatigue and cognitive function in healthy adults for claims that can be used for marketing.
Scientific title
Project ULTI: Evaluating the effect of the reformulated Ultivite and Ultivite 50 plus Multivitamin on energy, fatigue and cognitive function in healthy adults, which may then be used for advertising claims.
Secondary ID [1] 309968 0
NIL
Universal Trial Number (UTN)
U1111-1294-4116
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The behavioural effects of multivitamins on cognitive function in healthy volunteers. 330489 0
The influence of multivitamins on the physical state in healthy volunteers. 331057 0
Condition category
Condition code
Alternative and Complementary Medicine 327337 327337 0 0
Other alternative and complementary medicine
Mental Health 327357 327357 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 326429 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335226 0
Change in responses on measures relating to energy (which is measured by tiredness and activity).

Tool to assess the outcome: Study-specific questionnaire administered prior to taking the multivitamin to measure the participant's current energy levels. The same questionnaire is administered post taking the multivitamin to see the change in the respondent's energy levels.
Timepoint [1] 335226 0
One month / 30 days Prior to taking the multivitamin and One month / 30 days post consuming the multivitamin.
Secondary outcome [1] 423553 0
Change in responses on brain & mental function in regards to alertness.

Tool to assess the outcome: Study-specific questionnaire administered prior to taking the multivitamin to measure the participant's current state. The same questionnaire is administered post taking the multivitamin to see the change in the respondents state.
Timepoint [1] 423553 0
One month / 30 days Prior to taking the multivitamin and One month / 30 days post consuming the multivitamin.
Secondary outcome [2] 425507 0
Change in responses on brain & mental function in regards to concentration ability.

Tool to assess the outcome: Study-specific questionnaire administered prior to taking the multivitamin to measure the participant's current state. The same questionnaire is administered post taking the multivitamin to see the change in the respondents state.
Timepoint [2] 425507 0
One month / 30 days Prior to taking the multivitamin and One month / 30 days post consuming the multivitamin.
Secondary outcome [3] 425508 0
Change in responses on brain & mental function in regards to ability to cope with stress/life demands.

Tool to assess the outcome: Study-specific questionnaire administered prior to taking the multivitamin to measure the participant's current state. The same questionnaire is administered post taking the multivitamin to see the change in the respondents state.

Timepoint [3] 425508 0
One month / 30 days Prior to taking the multivitamin and One month / 30 days post consuming the multivitamin.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.'

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
We needed 100 participants per variety to try the product for 30 days in order to make the claims. Hence when we reached 100 participants per product variety (who have tried the product for 30 days), we stopped the data collection.
Date of first participant enrolment
Anticipated
Actual
17/04/2023
Date of last participant enrolment
Anticipated
Actual
17/07/2023
Date of last data collection
Anticipated
Actual
24/08/2023
Sample size
Target
1140
Accrual to date
Final
457
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 314142 0
Commercial sector/Industry
Name [1] 314142 0
Swisse Wellness Pty Ltd
Country [1] 314142 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Swisse Wellness Pty Ltd
Address
88 Landridge Street, Collingwood, Victoria 3066, Australia
Country
Australia
Secondary sponsor category [1] 316554 0
None
Name [1] 316554 0
Address [1] 316554 0
Country [1] 316554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313278 0
BELLBERRY HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 313278 0
123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [1] 313278 0
Australia
Date submitted for ethics approval [1] 313278 0
14/10/2022
Approval date [1] 313278 0
03/04/2023
Ethics approval number [1] 313278 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127578 0
Ms Parinaz Kharas
Address 127578 0
Nielsen Connect Australia Pty Ltd (“NielsenIQ”)., Suite 2, 14th Floor, 100 Walker Street, North Sydney, NSW, 2060
Country 127578 0
Australia
Phone 127578 0
+61 427098039
Fax 127578 0
Email 127578 0
[email protected]
Contact person for public queries
Name 127579 0
Parinaz Kharas
Address 127579 0
Nielsen Connect Australia Pty Ltd (“NielsenIQ”)., Suite 2, 14th Floor, 100 Walker Street, North Sydney, NSW, 2060
Country 127579 0
Australia
Phone 127579 0
+61 427098039
Fax 127579 0
Email 127579 0
[email protected]
Contact person for scientific queries
Name 127580 0
Parinaz Kharas
Address 127580 0
Nielsen Connect Australia Pty Ltd (“NielsenIQ”)., Suite 2, 14th Floor, 100 Walker Street, North Sydney, NSW, 2060
Country 127580 0
Australia
Phone 127580 0
+61 427098039
Fax 127580 0
Email 127580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.