Effect of a Nutritional Supplement on Mental Wellness in Adults

NCT06058364 | Completed DMC

• 1 other identifier: AFCRO-163
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 of this study is to determine if a unique orally consumed triglyceride supplement will impart mood benefits. Investigators hypothesize that a part of the fatty acids will be released in upper gastrointestinal (GI) tract and can be absorbed and reach different organs via systemic circulation (blood), including to the brain, and provide health benefits. Rest of the portion would reach the colon and may modulate gut microbiota and provide health benefits via the gut-brain axis (a bi-directional communication between emotional and cognitive centers and the gastrointestinal system). These health benefits could include alleviation of stress, occasional anxiousness and low mood. Participants with self-reported low mood will be randomized to two groups - one group will receive triglyceride supplement in softgel form and another group will receive a placebo (softgel with no active substance). Investigators will evaluate the effect of consumption of triglyceride supplement compared to Placebo on occasional low mood, occasional anxiousness, stress, sleep and general health by measuring changes from baseline.

Conditions

Low Mood

Keywords

triglyceride; fatty acids; mental wellness; mood; microbiome; gut-brain axis; dietary supplement

Outcome Measures

Primary Outcomes (1)

• 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).

  A change in self-reported symptoms of low mood assessed by Hospital Anxiety and Depression Scale - Depression (HADS-D) at baseline to week 8. HADS-D sub-score ranges from 0 - 21, where higher score is worse.

  From baseline to Week 8

Secondary Outcomes (6)

• To evaluate the effect of 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).

  From baseline to week 2 and week 4

• 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.

  From baseline to weeks 2, 4 and 8

• 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 sleep using Motionlogger Micro Watch (Sleep Watch) and Karolinska Sleepiness Scale (KSS).

  From baseline to weeks 2, 4 and 8

• 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

  From baseline to weeks 2, 4 and 8 or weeks 4 and 8

• 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

  From baseline to weeks 4 and 8

Other Outcomes (2)

• 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)

  From baseline to 8 weeks

• 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

  From baseline to 8 weeks

Study Arms (2)

Intervention 1

EXPERIMENTAL

Participants receiving triglyceride supplement

Dietary Supplement: Intervention 1 - Triglyceride

Intervention 2

PLACEBO COMPARATOR

Participants receiving placebo

Dietary Supplement: Intervention 2 - Placebo

Interventions

Intervention 1 - Triglyceride DIETARY_SUPPLEMENT

Triglyceride (1 softgel each morning with a glass of water)

Intervention 1

Intervention 2 - Placebo DIETARY_SUPPLEMENT

Placebo (1 softgel each morning with a glass of water)

Intervention 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmavite LLC: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Clinical Trials

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding of both study team and participants will be ensured by only providing access to the randomization list to the science and quality team. The relationship between the randomization number and the group assignment will be unknown to the participants, clinical study team, and the Sponsor, i.e. the study will be double-blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a double-blind randomized placebo controlled trial for a dietary supplement with two parallel groups - triglyceride supplement and placebo.

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 28, 2023
• Study Start: September 18, 2023
• Primary Completion: May 24, 2024
• Study Completion: October 8, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)