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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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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.
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 baseline determination or baseline visit (Visit 2; day 0), and three test visits (Visits 3, 4, and 5 at days 14, 28, and 56 respectively).
SCREENING
Visit 1 - Week -3
At Visit 1 (Screening visit) Participants will attend the study site and the following procedures will be carried out:
Participants will be given an appointment to return to the study site within 21 days for their baseline/day 1 visit.
INTERVENTION PHASE
Visit 2 - Day 0
Participants will complete a dual X-ray absorptiometry (DEXA) scan in advance of taking their first dose of study product, between Day -21 and Day 0.
Participants will attend this study visit and the following procedures will be carried out:
Participant's continued consent to study procedures will be confirmed.
Inclusion/exclusion criteria will be reviewed.
Adverse events will be recorded.
Concomitant medication/supplements will be recorded.
Weight will be measured, and BMI calculated.
Vitals (blood pressure, heart rate and temperature) will be recorded.
For individuals of childbearing potential, a urine sample will be collected, and pregnancy test performed (regardless of contraceptive use or relationship status).
Participants will return their saliva samples and samples will be stored for future analysis.
Participants will return their stool sample and sample will be stored for future analysis.
Participants will return their completed 3-day food diary.
Participants will return their completed Karolinska Sleepiness Scale (KSS) questionnaire.
Participants will have completed the following questionnaires within 24 hours of the visit:
Complete Hospital Anxiety and Depression (HADS) questionnaire.
A blood sample will be collected and stored for future biomarker analysis.
Participants will be provided with a stool collection kit and instructions for collecting and storing their sample. Participants will collect a stool sample at home, within 48 hours of their scheduled visit and bring it to the clinic at their next visit.
Participants will be provided with a saliva collection kit and instructions for collecting and storing their sample. Participants will collect a saliva sample at home, at T0, T30, T45, T60 minutes after waking on the morning of their scheduled visit and bring it to the clinic at their visit.
Participants will be provided with the Karolinska Sleepiness Scale (KSS). Participants will complete this 5 minutes after collecting T0 saliva sample on the morning of their scheduled visit and bring it to the clinic at their visit.
Participants will be reminded to complete the questionnaires with 24 hours of their next visit.
Participants will be provided with a watch for monitoring their sleep and instructions for how to wear and use the watch.
Participants will be randomized into one of two treatment groups as follows, but will be blinded as to which group, they are in:
Participants will be supplied with an 8-week supply of study product and instructions of dosing. Participants will be instructed to take one soft-gel capsule each day for the next eight weeks. An additional eight days of doses will be supplied in case of delay of study visit or loss of study product.
- Participants will be provided with an appointment to return to the study site in two weeks.
Visit 3 - Day 14
Participants will return to the study site at day 14 and the following procedures will be carried out:
Participant's continued consent to study procedures will be confirmed.
Adverse events will be recorded.
Concomitant medication/supplements will be recorded.
Data from the Participant's sleep watch will be reviewed and battery for the watch will be replaced.
Participants will return their saliva samples and samples will be stored for future analysis.
Participants will return their stool sample and sample will be stored for future analysis.
Participants will return their completed KSS questionnaire.
Participants will have completed the following questionnaires within 24 hours of the visit:
Complete Hospital Anxiety and Depression, HADS questionnaire.
A blood sample will be collected and stored for future biomarker analysis.
Participants will be provided with a stool collection kit and instructions for collecting and storing their sample. Participants will collect a stool sample at home, within 48 hours of their scheduled visit and bring it to the clinic at their next visit.
Participants will be provided with a saliva collection kit and instructions for collecting and storing their sample. Participants will collect a saliva sample at home, at T0, T30, T45, T60 minutes after waking on the morning of their scheduled visit and bring it to the clinic at their visit.
Participants will be provided with the Karolinska Sleepiness Scale (KSS). Participants will complete this 5 minutes after collecting T0 saliva sample on the morning of their scheduled visit and bring it to the clinic at their visit.
Participants will be reminded to complete the questionnaires with 24 hours of their next visit.
Participants will be provided with an appointment to return to the study site in two weeks.
Visit 4 - Day 28
Participants will return to the study site at day 28 and the following procedures will be carried out:
Participant's continued consent to study procedures will be confirmed.
Adverse events will be recorded.
Concomitant medication/supplements will be recorded.
Data from the Participant's sleep watch will be reviewed and battery for the watch will be replaced.
Participants will return their saliva samples and samples will be stored for future analysis.
Participants will return their stool sample and sample will be stored for future analysis.
Participants will return their completed Karolinska Sleepiness Scale (KSS) questionnaire.
Participants will have completed the following questionnaires within 24 hours of the visit:
Complete Hospital Anxiety and depression (HADS) questionnaire.
A blood sample will be collected and stored for future biomarker analysis.
Participants will be provided with a stool collection kit and instructions for collecting and storing their sample. Participants will collect a stool sample at home, within 48 hours of their scheduled visit and bring it to the clinic at their next visit.
Participants will be provided with a saliva collection kit and instructions for collecting and storing their sample. Participants will collect a saliva sample at home, at T0, T30, T45, T60 minutes after waking on the morning of their scheduled visit and bring it to the clinic at their visit.
Participants will be provided with the Karolinska Sleepiness Scale (KSS). Participants will complete this 5 minutes after collecting T0 saliva sample on the morning of their scheduled visit and bring it to the clinic at their visit.
Participants will be reminded to complete the questionnaires with 24 hours of their next visit.
Participants will be provided with a 3-day food diary and instructions on how to complete the document. Participants will return their completed diary at their next visit.
Participants will be provided with an appointment to return to the study site in two weeks.
Visit 5 (Final Visit) - Day 56
Participants will return to the study site at day 56 and the following procedures will be carried out:
Adverse events will be recorded.
Concomitant medication/supplements will be recorded.
Participants will return any unused study product and compliance will be assessed.
Participants will return their sleep watch and the data from the Participant's sleep watch will be reviewed.
Participants will return their saliva samples and samples will be stored for future analysis.
Participants will return their stool sample and sample will be stored for future analysis.
Participants will return their 3-day food diary.
Participants will return their completed Karolinska Sleepiness Scale (KSS) questionnaire.
Weight will be measured, and BMI calculated.
Vitals (blood pressure, heart rate and temperature) will be recorded.
Participants will have completed the following questionnaires within 24 hours of the visit:
Complete Hospital Anxiety and Depression (HADS) questionnaire.
The questionnaire data will be reviewed, and the app deleted from the participants device.
A blood sample will be collected for safety analysis.
A blood sample will be collected and stored for future biomarker analysis.
For participants of childbearing potential, a urine sample will be collected, and pregnancy test performed (regardless of contraceptive use or relationship status)
Participants will attend a DEXA scan 0 to 7 days after Visit 5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 1 | Experimental | Participants receiving triglyceride supplement |
|
| Intervention 2 | Placebo Comparator | Participants receiving placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention 1 - Triglyceride | Dietary Supplement | Triglyceride (1 softgel each morning with a glass of water) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | A change from baseline to week 2 and week 4, in self-reported mild to moderate symptoms assessed by Hospital Anxiety and Depression Scale, HADS Depression sub score (HADS-D), .which ranges from 0 - 21 and higher score is worse. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | A change from baseline to week 8 in fat mass as a percentage of total mass (%). | From baseline to 8 weeks |
Inclusion Criteria:
To be eligible for inclusion, the Participant must fulfil all the following criteria:
Exclusion Criteria:
Participants will be excluded from the study if they meet any of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Clinical Trials | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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This is a double-blind randomized placebo controlled trial for a dietary supplement with two parallel groups - triglyceride supplement and placebo.
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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.
| Intervention 2 - Placebo | Dietary Supplement | Placebo (1 softgel each morning with a glass of water) |
|
| 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. | A change from baseline to weeks 2, 4 and 8 in self-reported anxiety assessed by Hospital Anxiety and Depression Scale, HADS anxiety sub score (HADS-A).HADS-A sub score range from 0 - 21, where higher score is worse. | 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 | Short -Form 36 score ranges from 0 - 100. Higher scores indicate higher quality of life.
| 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 | A change from baseline to weeks 4 and 8 in perceived stress level assessed by Cohen's Perceived Stress Scale (PSS). Cohen's Perceived Stress Scale ranges from 0 - 40. Higher scores indicate greater perceived stress levels. | From baseline to 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 salivary cortisol |
| 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 gut microbial composition |
A change from baseline to week 8 in gut microbial composition as determined by shot gun sequencing of fecal DNA |
| From baseline to 8 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |