Status:
COMPLETED
Effect of a Nutritional Supplement on Mental Wellness in Adults
Lead Sponsor:
Pharmavite LLC
Collaborating Sponsors:
Atlantia Food Clinical Trials
Conditions:
Low Mood
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Trillions of microbes reside in human gut and constitute "gut microbiota". Composition of these microbes and substances produced by them play an important role in human health and wellness. The goal ...
Detailed Description
This is a randomized, placebo-controlled, double-blind, parallel study, which will include 5 visits over 10 week period - a screening visit (Visit 1; week -3), a 3-week run-in period followed by basel...
Eligibility Criteria
Inclusion
- To be eligible for inclusion, the Participant must fulfil all the following criteria:
- Be willing to participate in the study and comply with its procedures.
- Be able to give written informed consent.
- Adults aged between 18 and 65 years (inclusive).
- Participants with a BMI between ≥18.5 and \<30.0 kg/m\^2.
- Has self-reported mild-moderate low mood, confirmed by a Hospital Anxiety and Depression Scale (HADS - D) score 8 - 14.
- Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
- Be able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator.
Exclusion
- Participants will be excluded from the study if they meet any of the following criteria:
- Recent use of probiotics, prebiotics, postbiotic and other fermented foods that contain live bacteria within last 30 days from Visit 2.
- Recent use of any dietary supplements, within last 14 days from Visit 2.
- Participant who has been on antibiotics during the 90 days from Visit 2.
- Participant with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection.
- Participants who have started receiving cognitive behavioural therapy (CBT) or psychotherapy in the last 90 days prior to Visit 2 or plan to start during the period of the study.
- Participant who is severely immunocompromised (HIV positive, transplant patient, on anti-rejection medications, on a systemic steroid treatment for \>30 days, or chemotherapy or radiotherapy within the last year).
- Significant psychiatric diagnosis (e.g., bipolar), as diagnosed by a healthcare professional, including major depressive disorder (e.g., clinical depression) and anxiety disorder.
- Participants taking anti-depressants or herbal treatments for mood disorders or psychological conditions (e.g., valerian, St. John's Wort) within 90 days prior to Visit 2 or planning to start during the study period.
- Participants who are on anxiolytics, antipsychotics, anticonvulsants, antidepressants, opioid pain relievers, hypnotics, and/or prescribed sleep medication within 30 days prior to screening (Visit 1).
- Participants with a current history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment.
- Participants who consume any products containing Tetrahydrocannabinol (THC) and Cannabidiol (CBD) 30 days prior to screening (Visit 1).
- Participants who are unwilling to only consume butter or margarine once per day for the duration of the study.
- Participants with a fiber intake of \>18g/day
- Participants who are pregnant (determined by urine pregnancy test for all individuals of childbearing potential at screening, regardless of contraceptive use or relationship status), breastfeeding, or wish to become pregnant during the study.
- Have an acute or chronic illness (e.g., heart disease, uncontrolled hypertension, uncontrolled hypercholesterolemia, inflammatory bowel disease, cancer, HIV) that, in the Investigators judgment, precludes involvement in the study.
- Have had any other condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results.
- Change in prescribed medication, or major diet change in the 30 days prior to enrolment (Visit 2).
- Has received treatment involving experimental drugs in the past 90 days and experimental supplements in the past 60 days at the discretion of the investigator.
- Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06058364
Start Date
September 18 2023
End Date
October 8 2024
Last Update
November 7 2024
Active Locations (1)
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1
Atlantia Clinical Trials
Chicago, Illinois, United States, 60611