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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to weeks 2, 4 and 8 or weeks 4 and 8
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention 1Experimental Treatment1 Intervention
Participants receiving triglyceride supplement
Group II: Intervention 2Placebo Group1 Intervention
Participants receiving placebo

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Who is running the clinical trial?

Pharmavite LLCLead Sponsor
9 Previous Clinical Trials
26,584 Total Patients Enrolled
Atlantia Food Clinical TrialsIndustry Sponsor
41 Previous Clinical Trials
4,086 Total Patients Enrolled
1 Trials studying Depression
168 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include participants aged 55 and older?

"This medical study is open to patients aged 18-65."

Answered by AI

Is there an opportunity for me to participate in this research trial?

"This depression study is seeking 150 participants, aged 18 to 65 years old, with a BMI between ≥18.5 and <30.0 kg/m^2 that are willing to maintain consistent dietary habits and physical activity for the duration of the trial period."

Answered by AI

Are there any spots open in this clinical trial?

"The information posted on clinicaltrials.gov suggests that this scientific exploration is not presently accruing patients. Initially published on September 18th 2023 and last updated a few days later, the study has yet to start recruiting participants. Despite this, there are 1,226 other trials actively seeking candidates at the present moment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of a Nutritional Supplement on Mental Wellness in Adults
2023. "Effect of a Nutritional Supplement on Mental Wellness in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06058364.
All > Depression Chicago > Microbiome
~0 spots leftby May 2024
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