Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000159651
Ethics application status
Approved
Date submitted
3/02/2023
Date registered
16/02/2023
Date last updated
19/02/2024
Date data sharing statement initially provided
16/02/2023
Date results information initially provided
19/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
ConsumEr experieNce of supplement on mild to modERate symptoms of fatiGue or reduced vitalitY (ENERGY)
Scientific title
Investigating the effect of Swisse's body activator product on mild to moderate fatigue symptoms in middle-aged adults
Secondary ID [1] 308899 0
ACN002
Universal Trial Number (UTN)
Trial acronym
ENERGY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue 328893 0
Condition category
Condition code
Alternative and Complementary Medicine 325889 325889 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves the testing for eight weeks of a regulatory approved supplement.
The product Swisse Body Activator Support is TGA-listed (ARTG Entry: 391453). The post-marketing use of the product is as per label.

Dose administered: one hard capsule daily.
Timing: during or immediately after meal.
Route: Oral
Number of remaining capsules will be asked at weeks 4 and 8 to understand adherence via bespoke questionnaire developed ofr the study.
Intervention code [1] 325344 0
Treatment: Other
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333723 0
Change from baseline of Multidimensional Fatigue Symptom Inventory—Short Form (MSFI-SF) validated instrument total score
Timepoint [1] 333723 0
Baseline to 4 and 8 weeks (primary endpoint) post-intervention commencement
Secondary outcome [1] 418072 0
Change from baseline in of Fatigue Assessment Scale (FAS) validated instrument score
Timepoint [1] 418072 0
Baseline to 4 and 8 weeks post-intervention commencement
Secondary outcome [2] 418073 0
Change from baseline in of AQoL-6D validated instruments scores
Timepoint [2] 418073 0
Baseline to 4 and 8 weeks post-intervention commencement
Secondary outcome [3] 418074 0
Change from baseline in responses on energy, tiredness, fatigue, vitality, activity and vigour. This will be assessed as a composite outcome, using bespoke questionnaires developed for the study.
Timepoint [3] 418074 0
Baseline to 4 and 8 weeks post-intervention commencement

Eligibility
Key inclusion criteria
1. Evidence of an electronically signed and dated informed consent form indicating that the participant has been informed of all pertinent aspects of the study.

2. Aged between 40 and 65 years, both inclusive.

3. Self-reported mild-to-moderate symptoms of fatigue as measured by FAS score between 22 and 34 (Hendricks et al., 2018).

4. Self-reported absence of any chronic health conditions or co-morbidities, and absence of any medication relating to such conditions. With the exception of medically managed hypertension and associated medications, medically managed high cholesterol and associated medications and contraceptives.

5. Body mass index (BMI) lower than 35 kg/m2

6. 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 3 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 at least 1 month prior to study inclusion and throughout the study OR
• have no sexual intercourse and agreeing not to have any throughout the study OR
• are surgically sterile (oophorectomy, hysterectomy or tubal ligation). OR
• are having non-childbearing potential sex - e.g., vasectomised partner, same-sex relationship OR

7. Individuals who agree to continue their “usual” exercise routine during the study period.

Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individuals with significant past medical and psychiatric history and ongoing chronic conditions, including mental health disorder (e.g., depression, anxiety-related disorder, eating disorder, psychosis/schizophrenia) or medical illness including diabetes, autoimmune diseases, cardiovascular disease, hypertension, chronic fatigue syndrome, or asthma (medically managed hypertension and medically managed high cholesterol are acceptable).

2. Individuals who are pregnant and/or lactating, or who are planning to become pregnant during the study or four (4) weeks after the study

3. Individuals who have taken any of the following supplements in the last 14 days (e.g., (multi)vitamins, Vitamin B, Magnesium or any other supplements (vitamins/minerals or herbals) that target physical energy and/or mental stamina.

4. Individuals who performed/followed a meal replacement regimen or extreme caloric restriction diet (considered lower than 60% normal caloric intake) in the last 30 days.

5. Individuals with known or suspected intolerance or hypersensitivity to soya beans, the product ingredients (or closely related compounds) or any of their stated ingredients i.e., Nicotinamide Riboside Chloride, Magnesium, Vitamin E, Selenium, Turmeric and Black Pepper.

6. Individuals who have participated in any other interventional study or have received any investigational drug within 30 days of the screening.

7. Individuals categorised as an elite athlete by their National Sporting Organisation (NSO) or another relevant organisation.

8. Individuals who abuse substances (i.e., alcohol, cannabis, hallucinogens, cocaine, opioids, and sedatives)

9. 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.

A standard drink contains 10 grams of pure alcohol. Standard drink examples are the following:
• Light beer (2.7% alc/vol) 425 mL
• Mid strength beer (3.5% alc/vol) 375 mL
• Full strength beer (4.9% alc/vol) 285 mL
• Regular cider (4.9% alc/vol) 285 mL
• Sparkling wine (13% alc/vol) 100 mL
• Wine (13% alc/vol) 100 mL
• Fortified wine e.g., sherry, port (20% alc/vol) 60 mL
• Spirits e.g., vodka, gin, rum, whiskey (40% alc/vol) 30 mL

10. 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.

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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/03/2023
Actual
31/03/2023
Date of last participant enrolment
Anticipated
31/10/2023
Actual
10/10/2023
Date of last data collection
Anticipated
31/12/2023
Actual
20/12/2023
Sample size
Target
240
Accrual to date
Final
320
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313109 0
Commercial sector/Industry
Name [1] 313109 0
Swisse Wellness Pty Ltd
Country [1] 313109 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Swisse Wellness Pty Ltd
Address
88 Langridge Street , Collingwood, Victoria 3066
Country
Australia
Secondary sponsor category [1] 314808 0
None
Name [1] 314808 0
Address [1] 314808 0
Country [1] 314808 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312358 0
Bellberry Limited
Ethics committee address [1] 312358 0
123 Glen Osmond Road, Eastwood SA 5063
Ethics committee country [1] 312358 0
Australia
Date submitted for ethics approval [1] 312358 0
29/11/2022
Approval date [1] 312358 0
20/03/2023
Ethics approval number [1] 312358 0
2022-11-1300

Summary
Brief summary
This study involves the testing for eight weeks of a regulatory listed supplement targeting fatigue symptoms.

This real-world direct-to-participant study aims to understand healthy volunteers’ perspectives and experiences using the TGA-listed and marketed Swisse Body Activator product to generate advertisement claims within the regulatory permitted indications/label.

Patients will be recruited via a consumer panel or through social media or other virtual channels via an online screening survey.

The Swisse Body Activator product (ARTG ID: 391453, June 2022) is a hard oral capsule with a comprehensive formulation that targets physical fatigue, energy management and inflammation. It has several permitted indications – Maintain/support energy levels and vitality, relieve weariness, tiredness, fatigue and the feeling of weakness and decrease, reduce, and relieve mild joint inflammation, swelling, pain and soreness, among others.
Trial website
https://trials.evrima.com/fatigue-research-study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124370 0
Mrs Maureen Hitschfeld
Address 124370 0
IQVIA Solutions Australia Pty Ltd, Level 8, 141 Walker Street North Sydney NSW 2060 Australia
Country 124370 0
Australia
Phone 124370 0
+61 423641270
Fax 124370 0
Email 124370 0
[email protected]
Contact person for public queries
Name 124371 0
Mrs Maureen Hitschfeld
Address 124371 0
IQVIA Solutions Australia Pty Ltd, Level 8, 141 Walker Street North Sydney NSW 2060 Australia
Country 124371 0
Australia
Phone 124371 0
+61 423641270
Fax 124371 0
Email 124371 0
[email protected]
Contact person for scientific queries
Name 124372 0
Mrs Maureen Hitschfeld
Address 124372 0
IQVIA Solutions Australia Pty Ltd, Level 8, 141 Walker Street North Sydney NSW 2060 Australia
Country 124372 0
Australia
Phone 124372 0
+61 423641270
Fax 124372 0
Email 124372 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
Just aggregated data will be made publicly available.


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.