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

NCT06768970 | Completed

• 1 other identifier: OmeGo-Sleep-001
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep; Pollution; Exposure; Cough

Keywords

salmon oil; sleep quality; environmental pollution; decentralized; virtual platform; clinical trial

Outcome Measures

Primary Outcomes (2)

• The impact of OmeGo capsules on sleep quantity and quality

  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

  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 Outcomes (2)

• Subjective Sleep Quality

  Baseline to 8 weeks

• Pro- and Anti-Inflammatory Gene Expression

  Baseline to 8 weeks

Other Outcomes (1)

• Correlation Between AQI and Cough Severity

  Baseline to 8 weeks

Study Arms (2)

CARDIO® Capsules (2.0 g)

EXPERIMENTAL

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® Capsules (4.0 g)

EXPERIMENTAL

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

Interventions

CARDIO® salmon oil DIETARY_SUPPLEMENT

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.

Also known as: OmeGo

CARDIO® Capsules (2.0 g); CARDIO® Capsules (4.0 g)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hofseth Biocare ASA: lead

Study Sites (1)

Alethios, Inc.

San Francisco, California, 94109, United States

Location

MeSH Terms

Conditions

Cough; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: January 10, 2025
• Study Start: May 14, 2024
• Primary Completion: November 15, 2024
• Study Completion: January 5, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)