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Nutritional Supplement for Mental Wellness

N/A

Recruiting

Research Sponsored by Pharmavite LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged between 18 and 65 years (inclusive)

Participants with a BMI between ≥18.5 and <30.0 kg/m^2

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to weeks 2, 4 and 8 or weeks 4 and 8

Summary

This trial seeks to understand if taking a triglyceride supplement can help with stress, anxiousness, low mood, sleep and general health.

Who is the study for?

Adults aged 18-65 with mild to moderate low mood, as indicated by a specific score on a depression scale, can join this trial. They must not have used dietary supplements or antibiotics recently, be undergoing certain therapies, or have major psychiatric diagnoses. Participants should maintain their usual diet and exercise routines during the study.

What is being tested?

The trial is testing whether taking a triglyceride supplement improves mental wellness compared to a placebo. The supplement might work through the gut-brain axis by affecting both brain function directly and gut microbes indirectly. Mood, stress levels, sleep quality, and general health will be measured before and after treatment.

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information but could include digestive discomfort due to changes in gut microbiota from the triglyceride supplement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My BMI is between 18.5 and 30.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am severely immunocompromised due to conditions like HIV, being a transplant recipient, or recent treatments.

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I have been diagnosed with a significant psychiatric condition like bipolar disorder, major depression, or anxiety.

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I have taken medication for anxiety, psychosis, seizures, depression, pain, or sleep within the last 30 days.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I haven't taken anti-depressants or herbal mood treatments in the last 90 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to weeks 2, 4 and 8 or weeks 4 and 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to weeks 2, 4 and 8 or weeks 4 and 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to weeks 2, 4 and 8 or weeks 4 and 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the effect of eight weeks consumption of triglyceride supplement compared to Placebo on low mood in a population with self-reported mild to moderate symptoms (Hospital Anxiety and Depression Scale - Depression, HADS-D score of 8 - 14).

Secondary study objectives

To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on Stress

To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on anxiety.

To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on general health, physical functioning and energy

+3 more

Other study objectives

To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on fat mass measured by dual X-ray absorptiometry (DEXA)

To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on gut microbial composition