The effects of 3FDC dietary supplementation on psychological functioning in an adult populatio

Phase 1

• Conditions: Psychological Health; Depression; Anxiety; Stress; Gut Function; Biochemical Health; Mental Health - Other mental health disorders; Mental Health - Studies of normal psychology, cognitive function and behaviour; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12621000714886
• Lead Sponsor: Anatara Lifesciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Study Completion: 2022-10-07
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified