NCT06768970

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Hofseth Biocare ASA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Sleep
• Pollution; Exposure
• Cough

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-14
• Primary completion: 2024-11-15
• Completion: 2025-01-05
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

1 site across 1 country: United States