None listed
Conditions
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.
Interventions
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.
Sponsors
Swisse Wellness Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed