None listed
Conditions
Brief summary
The aim of this study is to investigate the effects of a novel dietary supplement (3DFC) on psychological functioning and other health related outcomes including mood, wellbeing, biochemical parameters, heart rate variability and gut symptoms in adults aged 18-55 years with elevated stress, anxiety and depression symptoms. The 3DFC supplement developed by the principal trial sponsor (Anatara Lifesciences) contains elevated levels of sodium butyrate and is designed to be metabolised by the gut microbiota. The 3FDC supplement has the potential to produce benefits in the outcomes described. The CSIRO will lead a 6-week randomised, double-blind placebo-controlled trial consisting of two intervention arms: 1) the 3DFC dietary supplement; and 2) placebo control. It is expected that the 3FDC supplement will lead to a greater reduction in anxiety and depression subscale scores on the Hospital Anxiety and Depression Scale compared to a placebo over the 6 week period.
Interventions
Active Intervention: Dosed with oral 3FDC mini-tablets, equivalent to 1200 mg sodium butyrate, twice a day for 6 weeks.
Compliance will be monitored throughout the study. Participants will complete a daily record via a mobile app or a paper-based log for the duration of the 6-week intervention period to record study protocol compliance. Any queries from the logs will be followed up via a phone call. Participants who consume less than 80% of the required product in a given fortnight will receive
Active Intervention: Dosed with oral 3FDC mini-tablets, equivalent to 1200 mg sodium butyrate, twice a day for 6 weeks. Compliance will be monitored throughout the study. Participants will complete a daily record via a mobile app or a paper-based log for the duration of the 6-week intervention period to record study protocol compliance. Any queries from the logs will be followed up via a phone call. Participants who consume less than 80% of the required product in a given fortnight will receive a courtesy call from site study staff to problem solve compliance issues. Subjects will be instructed to bring back any remaining product to site for accountability purposes.
Sponsors
Anatara Lifesciences
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Willing to provide written Informed Consent 2. Access to a smartphone and willing to download a free application from the app store 3. Able to access own email address 4. Male or female 5. Aged greater than or equal to 18 & <56 years 6. Body mass index (BMI) greater than or equal to 18.5 kg/m2 and less than or equal to 35 kg/m2 confirmed at clinic screening 7. Scores in the mild range on a minimum of two of the DASS-21 subscales (Depression: greater than or equal to 10 & less than or equal to 13, Anxiety: greater than or equal to 8 & less than or equal to 9, Stress: greater than or equal to 15 & less than or equal to 18) or scores in the moderate range on a minimum of one of the subscales (Depression: greater than or equal to 14 & less than or equal to 20, Anxiety: greater than or equal to 10 & less than or equal to 14, Stress: greater than or equal to 19 & less than or equal to 25) and no scores in the severe or extremely severe range on any of the subscales (Depression: greater than or equal to 21, Anxiety: greater than or equal to 15, and Stress: greater than or equal to 26).
Exclusion criteria
1. Use of any of the following types of supplements within 28 days of clinic screening and not prepared to abstain from use for the study duration: • Supplements containing prebiotics or probiotics • Fibre supplements (e.g., psyllium plant sterols, Metamucil, Benefibre) 2. Use of any of the following types of prescribed medications within 84 days of clinic screening (for a full list see Appendix A): • Antidepressants • Anxiolytics • Narcotics • Stimulants • Anti-psychotics • Antibiotics • Systemic steroids (e.g., prednisolone) • Chronic drug therapy that interferes with vitamin D metabolism, such as glucocorticoids (e.g., dexamethasone) 3. Currently participating in psychological therapy with a mental health clinician (including but not limited to psychologist, counsellor, GP) 4. Participation in nightshift work within 28 days of clinic screening 5. Have a significant acute or chronic illness (psychiatric, gastrointestinal, cardiovascular [except uncontrolled hypertension], endocrine or immunological) or any condition that in the opinion of the PI or Designee may affect the applicant’s ability to participate in the study or the study results 6. Have experienced a cardiovascular event such as congestive heart failure, heart attack, stroke or angina (chest pain) in the past 84 days 7. Currently have, or have a history of, inflammatory bowel disease (e.g., ulcerative colitis, Chron’s disease) 8. Have had previous brain surgery, heart surgery (.e.g., coronary artery bypass surgery), gastrointestinal surgery or other surgery that in the opinion of the PI or Designee may affect the participant’s ability to participate in the study or the study results 9. Smoking/vaping (i.e., history of smoking/vaping within the last six months) 10. Women of childbearing potential (WOCBP) who: a) Are not currently using effective methods of contraception and b) Have not been using effective methods of contraception for 14 days prior to clinic screening and c) Are not willing to use effective methods of contraception throughout the study 11. WOCBP who are currently pregnant or lactating 12. Aversion and/or intolerance/allergy to cellulose 13. Currently hospitalised or any planned hospitalisations during the study that may affect the participant’s ability to comply with the study in the opinion of the Principal Investigator 14. Participated in a clinical trial within 28 days prior to clinic screening that in the opinion of the PI or Designee may affect the applicant’s ability to participate in the study or the study results 15. Blood haematology and biochemistry test results outside the normal reference range at screening and considered clinically significant by the PI or Designee
Outcome results
None listed