Case Study: Hofseth BioCare

At a Glance

Study Record

Company

Hofseth BioCare, a Norwegian biotech company producing marine-derived nutritional ingredients

Product

OmeGo® Salmon Oil capsules

Study

A 10-week, fully virtual randomized trial—8 weeks of daily supplementation preceded by a 14-day run-in period—testing two doses of OmeGo® Salmon Oil against sleep disruption and cough linked to urban air pollution and respiratory symptoms

Results

Full enrollment reached, 96.9% participant completion rate, and continuous sleep data from 127 connected wearable devices.

Timeline

From study design to peer-reviewed publication in Nutrition and Food Technology: Open Access in under 10 months (submitted February 6, 2025; accepted March 21; published March 27, 2025)

The Challenge

Hofseth BioCare wanted to determine whether OmeGo® Salmon Oil could support sleep quality in people whose sleep was disrupted by air pollution and respiratory symptoms—a population that isn't concentrated near any single site. The study required real-world data that couldn't be adequately captured during occasional clinic visits, along with participant diversity that's hard to find in a single geographic location. Recruiting a group that varied, geographically and demographically, through conventional trial centers would have meant standing up multiple physical recruitment sites—each adding cost and coordination overhead before a single participant enrolled, and creating adherence challenges throughout the study.

How This Compares

Traditional site-based trials don't just move slower; they also tend to enroll narrower populations. A Cochrane systematic review found a median of 2.1 years between trial completion and publication (4.8 years from first patient enrollment), and that only 53% of trials are ever published in a journal at all (Cochrane). Median Phase III enrollment periods have stretched from 13 months (2008–2011) to 18 months (2016–2019), and more than 80% of trials miss their original enrollment timeline entirely (IQVIA data via dataally.ai). Representation suffers along the way, too: a National Academies review found Hispanic and Black patients are 28% and 29% less likely to enroll in cancer trials than white patients, even after adjusting for incidence and age (NCBI Bookshelf). In-person trials raise participant burden, requiring travel to the site and a schedule that works for both participant and researcher. These issues are consequential, influencing who is able to join studies, who can stay in them despite logistical barriers, and who is represented in the results.

Against that backdrop, a study that reached full enrollment, ran to completion, and reached peer-reviewed publication in under 10 months isn't just fast—it's a timeline and reach that traditional site-based research and other, less comprehensive decentralized models aren’t built to produce.

The Solution

Rather than compromising the scope of their study with in-person sites and individual clinic visits, Hofseth BioCare ran its study entirely on Alethios, allowing for continuous data collection and a far wider reach for participant recruitment.

In practice, the decentralized study looked like this:

Participants enrolled online.
After remote onboarding, participants received their assigned dose of OmeGo® Salmon Oil by mail.
Participants connected their own wearable device—Apple Watch, Google Fit, Garmin, Oura, Whoop, or FitBit—in a bring-your-own-device format where participants used whatever device they already owned.

From there, sleep data streamed automatically from participants' wearables to Hofseth BioCare's research team, alongside daily self-reported surveys on cough and sleep quality and, for participants who opted in, a nasal swab collected at three points during the study. Compensation—$75 for completion, plus an optional $25 for the nasal swab—was built into the same digital workflow, with no separate site visits required.

The trial was registered on ClinicalTrials.gov (NCT06768970), approved by Sterling IRB, and conducted in accordance with the Declaration of Helsinki and ICH/Good Clinical Practice standards—the same regulatory rigor expected of a traditional site-based trial, without the traditional site.

The Results

The Hofseth BioCare OmeGo® study reached full enrollment, with 96.9% completion, and closed with a 94% participant adherence rate. Throughout the study, participants reported their perceived cough severity and sleep quality daily, 32 participants completed nasal swabs to assess changes in gene expression of relevant cytokines and chemokines, and 127 participants contributed continuous sleep data from their wearable devices.

The study's remote reach produced a mixed participant pool: the 2g arm was 58% Caucasian, 15% African-American, 10% Asian, 3% Latino/Hispanic, and 10% mixed-race; the 4g arm was 43% Caucasian, 16% African-American, 21% Asian, 9% Latino/Hispanic, and 10% mixed-race, with a mean participant age in the early 40s across both groups—demographic diversity that is difficult to attain without many in-person trial sites.

Using decentralized data collection, Hofseth BioCare ended up with robust evidence—the published results were statistically significant: cough severity dropped 15–20mm on a 100mm visual analogue scale (p<0.001 across both doses), self-reported sleep quality improved significantly in both dosage groups, and several inflammatory markers showed significant reductions in nasal swab samples.

The breadth of data collected in the study would have been difficult, if possible at all, to gather in an on-site trial. As stated in the published paper:

From the published paper

"By leveraging Alethios, this study ensured efficient participant engagement, real-time data monitoring, and adherence to Good Clinical Practice (GCP) guidelines. This approach enhanced study accessibility and reduced logistical barriers associated with traditional site-based trials."

What It Means

Using Alethios’ software platform, Hofseth BioCare did not just achieve the comprehensiveness and rigor of an on-site trial, it achieved more and did it faster.

In the customer’s words

"The Alethios platform has enabled the rapid recruitment of a diverse participant population which will provide health outcomes data relevant to the population as a whole. This would otherwise only have been achievable with a large number of recruitment centers, adding complexity and cost."

"The contrast to recruitment at conventional trial centres is stark and hugely positive. The broad reach of the digital platform not only shrinks recruitment timelines manyfold, it also results in a trial population that better reflects the population in general."

Crawford Currie

Head of Medical R&D at Hofseth BioCare

For Hofseth BioCare, a faster, broader-reaching recruitment process means more studies can fit into the same development timeline—data that feeds directly into substantiating the next health claim for its marine-derived ingredient line.

Concept to Peer-Reviewed Publication in 10 Months