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

NCT ID: NCT06150261

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-08
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

AvailOm

Availom capsules will be administered orally in a dose of 5 capsules/day per individum for a total of 6 months.

Group Type: EXPERIMENTAL

AvailOm

Intervention Type: DIETARY_SUPPLEMENT

5 capsules taken once daily with main meal

Placebo

Placebo capsules matching AvailOm will be administered orally in a dose of 5 capsules/day per individum for a total of 6 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

5 capsules taken once daily with main meal

Interventions

AvailOm

5 capsules taken once daily with main meal

Intervention Type: DIETARY_SUPPLEMENT

Placebo

5 capsules taken once daily with main meal

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Aged 55 or more
• BMI between 25-30,
• Waist-to-hip ratio of at least 0.90 (males) or 0.85 (females)
• Omega-3 index <6

Exclusion Criteria

• Dementia
• Current clinically significant depression, i.e. major depression or GDS 15 score >7
• Ischemic or haemorrhagic Stroke
• Acute myocardial infarction
• Any form of clinically significant atherosclerotic cardiovascular disease
• Unstable angina pectoris
• Hearth failure in need of treatment
• Diabetes mellitus type 1 or 2
• Clinically relevant kidney diseases that require dialysis, including clinically significant chronic kidney disease
• Liver cirrhosis or active hepatitis B or C
• Cancer of any kind; however, benign tumours are no exclusion criterium
• Clinically relevant inflammatory or autoimmune disorders with history of hospitalisation
• Any form of systemic lupus erythematosus (SLE), rheumatoid arthritis, Colitis ulcerosa, Crohn's disease, Morbus Parkinson, Multiple Sclerosis
• hsCRP > 3.0 mg/L to exclude high risk individuals according to international criteria
• LDL-C > 160mg/dL to exclude individuals with high risk for arterioscleratic coronary disease26
• HBa1C < 6.5% to exclude diabetes
• Fasting Triglycerides >200 mg/dL
• Omega 3 index > 6 % (as they may not show any benefit from supplementation)
• Use of fish oil / omega 3 supplements over the last 6 months
• Fish allergy
• Antibiotic use in the last 24 weeks

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Evonik Industries AG

UNKNOWN

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dag Aarsland, PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

Stavanger Universitetssjukehus

Stavanger, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Dag Aarsland, PhD

Role: CONTACT

dag.arsland@sus.no

+47 51515062

Facility Contacts

Dag Aarsland, Phd

Role: primary

+47 51 51 56 19

Other Identifiers

AvailOm

Identifier Type: -

Identifier Source: org_study_id