NCT06150261

Effects of an Omega-3 Fatty Acid-based Supplement on Healthy Ageing

Tolerability and Effects of a New Omega-3 Fatty Acid-based Supplement on Clinical and Biological Markers of Healthy Ageing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: 55 Years – 100 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomised, double-blind placebo controlled trial is to explore tolerability and the effects of a new omega-3 fatty acid-based supplement on biological and clinical aspects relevant for healthy ageing. Participants will be asked to take a supplement or a placebo for 6 months, and to attend the clinic a total of 3 times and to perform or submit the following: * Physical examination * Muscle function tests * Cognitive testing * Questionnaire completion * Biological samples, including blood, saliva and faeces. Researchers will compare the results from the group taking the supplement to the results of the group taking a placebo to see if the supplement has an effect on biological and clinical aspects associated with healthy ageing.

Detailed description

Healthy ageing is the process of developing and maintaining the functional ability that is associated with wellbeing across the life course and comprises mental and physical capacities such as the ability to walk, think, see, hear and remember. These factors are influenced by several factors including diseases, age-related decline in organ function and lifestyle such as diet and physical exercise. Among dietary factors, omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are increasingly recognized as potentially promoting healthy ageing, including benefits to cardiovascular system, as well as muscle function, and brain function. It is also important for brain and eye development. Regular supplementation with EPA and DHA therefore potentially offers a range of health benefits throughout life. Since humans cannot synthesize omega-3 fatty acids, these are considered essential nutrients and must be incorporated into the diet, with the main source for EPA and DHA incorporation being fish oils and supplementation. Western diets are often deficient in these compounds, therefore, regular supplementation with EPA and DHA potentially delays functional decline in ageing and reduces the incidence / severity of age-related diseases. Objective/Aims: Explore tolerability and the effects of the IP on biological and clinical aspects relevant for healthy aging. Design: Randomized, double-blind placebo-controlled parallel-group trial for six months.

Conditions

• Healthy Aging
• Ageing Well

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AvailOm	5 capsules taken once daily with main meal
DIETARY_SUPPLEMENT	Placebo	5 capsules taken once daily with main meal

Timeline

• Start date: 2023-12-08
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2023-11-29
• Last updated: 2025-01-14

Locations

1 site across 1 country: Norway