Investigating the Effect of Daily CARDIO® Capsules Supplementation on Improved Sleep in Healthy, Urban-Dwelling Adults

January 9, 2025 updated by: Hofseth Biocare ASA

A Decentralized Clinical Trial to Investigate the Effect of Daily Cardio Capsules (US FDA NDI) Supplementation on Improved Sleep in Healthy, Urban-Dwelling Adult Participants

This study aims to explore the impact of supplementation with CARDIO® whole salmon oil capsules on healthy adult participants with sleep disruption related to particulate matter pollution. The trial will employ a decentralized approach enabled by modern technology and wearables to measure sleep quantity and quality. Validated patient reported outcome (PRO) measures will be employed to measure the impact on cough and the subjective assessment of sleep quality and wellbeing. After a two week run-in period, subjects will be randomized to OmeGo at either 2g or 4g daily for 8 weeks. Final assessment will be at week 10.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to explore the impact of a nutritional supplement, CARDIO® salmon oil, on sleep quality and cough among adults residing in urban areas with air quality index / AQI 50 or higher. The trial will employ a decentralized approach enabled by modern technology and wearables. The co-primary endpoint is sleep quality, as measured by wearable device, and impact on cough measured via patient reported outcomes (visual analogue scale / VAS). Secondary endpoints will measure subjective change in sleep via participant-reported VAS and voluntary nasal swabs will be taken in up to 40 participants to assess change in gene expression of relevant cytokines and chemokines. Due to the exploratory nature of this study a placebo arm is not being employed, rather participants will be randomized to CARDIO® at either 2g or 4g daily for 8 weeks following a two-week run-in period where baseline sleep metrics will be recorded by wearable device and the Epworth Sleepiness Scale to measure daytime sleepiness. Final assessment will be undertaken in week 10.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
        • Alethios, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age

    • Participants must be between 18 and 70 years of age.

  • Technological access

    • Must possess the ability to access and operate a mobile or web-based device manufactured after 2008.
  • Sleep disturbed by coughing resulting in daytime tiredness
  • Level of cough burden over previous 24 hours self-scored at ≥40mm on the 0mm ("no cough problems") to 100mm ("most troublesome cough") cough level on visual analog scale (VAS) at screening and baseline

  • Wearable Technology

    • Ownership of a wearable device that collects and records time spent in different sleep stages (e.g., REM, Deep, Light, Awake), such as an Apple Watch, Whoop, Google Fit, Fitbit, Garmin, or Oura ring device.

Exclusion Criteria:

Medication Restrictions:

  • Use of neuromodulatory therapy (latter including gabapentin, pregabalin, morphine and amitriptyline).
  • Current use of ACE (angiotensin converting enzyme) inhibitors or have taken an ACE inhibitor within 3 months of screening.

Pregnant or lactating women

Smoking Status:

● Individuals who are smokers or have smoked within the past 12 months.

Sleep Aid Limitations:

● Use of prescription or over-the-counter sleep aids, including both wellness and prescribed medications.

Sleep Disorder Diagnosis:

  • The presence of diagnosed sleep disorders. Alcohol
  • Alcohol abuse (4 drinks per day for women and more than 12 per week and 5 or more per day for men or more than 15 drinks per week) or substance use disorder.

Supplement Constraints:

● Use of fish oil, other marine oils (including algal or krill) and omega supplements is not allowed for the duration of the study, with a prerequisite of abstaining from these supplements for at least 3 months prior to participation.

Allergic to fish Epworth Sleepiness Scale score of ≥16

• Any participant with a score of ≥16 will be advised to seek medical attention before entering the study to ensure that they have no undiagnosed medical conditions. If they are deemed medically fit and well they will be able to continue in the study.

Lifestyle Considerations No change in dietary habits, caffeine or alcohol intake or activities of daily living.

No shift work involving night shifts No change in use of vitamins and minerals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CARDIO® Capsules (2.0 g)
The study intervention entails CARDIO® salmon oil supplementation, a nutritional product containing a full spectrum of omega fatty acids. Participants allocated to the 2g/d arm will receive two capsules daily as their dosage regimen.
Dietary supplement: CARDIO® salmon oil
CARDIO® is a natural salmon oil manufactured from the enzymatic hydrolysis of Norwegian Atlantic salmon. Salmon capsules contain a full spectrum omega- and non-omega marine fatty acids with naturally occurring astaxanthin.
Other Names:
  • OmeGo
Experimental: CARDIO® Capsules (4.0 g)
The study intervention entails CARDIO® salmon oil supplementation, a nutritional product containing a full spectrum of omega fatty acids. Participants allocated to the 4g/d arm will receive four capsules daily as their dosage regimen.
Dietary supplement: CARDIO® salmon oil
CARDIO® is a natural salmon oil manufactured from the enzymatic hydrolysis of Norwegian Atlantic salmon. Salmon capsules contain a full spectrum omega- and non-omega marine fatty acids with naturally occurring astaxanthin.
Other Names:
  • OmeGo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The impact of OmeGo capsules on sleep quantity and quality
Time Frame: Baseline to week 10.
Change in sleep quantity and quality to be measured via change in total sleep time (TST) and waking after sleep onset (WASO) via the use of wearables.
Baseline to week 10.
The impact of CARDIO capsules on cough symptoms from baseline to end of study
Time Frame: Baseline to week 10
VAS score will be used to assess cough over the preceding 24 hours, measured each morning, on a 100mm scale. The VAS is easy and simple to complete and has been shown to be highly responsive to change in cough symptoms
Baseline to week 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective Sleep Quality
Time Frame: Baseline to 8 weeks
Subjective assessment of sleep quality via 100mm VAS with 0mm representing the "best possible sleep" and 100mm representing the "worst possible sleep".
Baseline to 8 weeks
Pro- and Anti-Inflammatory Gene Expression
Time Frame: Baseline to 8 weeks
Change in gene expression of inflammatory and anti-inflammatory genes (CSF2, CXCL8, IL10, TNF, IL6, IL4, IL5, TGFB1, IL13, BMP2, CRP) encoding cytokines and chemokines will be assessed using nasal swab specimens. Quantitative real-time PCR (qRT-PCR) with TaqMan probe technology will be utilized to measure gene expression levels. This analysis is voluntary and will be conducted in up to 40 subjects.
Baseline to 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation Between AQI and Cough Severity
Time Frame: Baseline to 8 weeks
Explore the potential correlation between AQI (numerical index on standardized scale) in participants' neighborhoods and cough severity (on a 100-mm linear scale ranging from "no cough" [0 mm] to "worst cough" [100 mm] ) during the intervention period. Correlation will be assessed using Pearson correlation coefficient.
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hofseth Biocare ASA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OmeGo-Sleep-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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