Clinical trial NCT06150261: Effects of an Omega-3 Fatty Acid-based Supplement on Healthy Ageing
Official title: Tolerability and Effects of a New Omega-3 Fatty Acid-based Supplement on Clinical and Biological Markers of Healthy Ageing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Aging
Ageing Well
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Evonik Industries AG
First posted: 2023-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, double-blind placebocontrolled, paralell-group trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Effects of Availom on DNA methylation
timeFrame: 6 months
Secondary outcomes:
measure: Effects of Availom on inflammation
timeFrame: 6 months
measure: Effects of Availom on plasma lipids
timeFrame: 6 months
measure: Effects of Availom on in vitro neurogenesis markers
timeFrame: 6 months
measure: Effects of Availom on brain-derived neurotrophic factor
timeFrame: 6 months
measure: Effect of Availom on microbiome changes
timeFrame: 6 months
measure: Investigate potential moderators of the effect of Availom on microbial composition
timeFrame: 6 months
measure: Effects of Availom on cognition as measured by use of MoCA
timeFrame: 6 months
measure: Effects of Availom on cognition as measured by use of CERAD
timeFrame: 6 months
measure: Effects of Availom on muscle function as asessed by TUG
timeFrame: 6 months
measure: Effects of Availom on muscle function as assessed by grip strength
timeFrame: 6 months
measure: Effects of genotype on association between Availom and genotype
timeFrame: 6 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger Universitetssjukehus
Study officials:
affiliation: Helse Stavanger HF
name: Dag Aarsland, PhD
role: PRINCIPAL_INVESTIGATOR
References: