Healthy AgingNCT06150261
Effects of an Omega-3 Fatty Acid-based Supplement on Healthy Ageing
A study testing AvailOm in people with Healthy Aging and Ageing Well, run by Helse Stavanger HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Ageing Well
- What is being tested?
- AvailOm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 8 Dec 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Stavanger Universitetssjukehus
Stavanger
Dag Aarsland, Phd, +47 51 51 56 19
About this study
Official title: Tolerability and Effects of a New Omega-3 Fatty Acid-based Supplement on Clinical and Biological Markers of Healthy Ageing
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:
Read more
- 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.
Read the 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
- Being tested
- AvailOm, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvailOmDietary supplement
5 capsules taken once daily with main meal
PlaceboDietary supplement
5 capsules taken once daily with main meal
| Study group | Role | What they receive |
|---|---|---|
| AvailOm | Experimental | Availom capsules will be administered orally in a dose of 5 capsules/day per individum for a total of 6 months. Receives: Dietary Supplement: AvailOm |
| Placebo | Placebo comparator | Placebo capsules matching AvailOm will be administered orally in a dose of 5 capsules/day per individum for a total of 6 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Availom on DNA methylation
Effects of Availom on DNA methylation will be measured by a novel saliva-based method and correlated with the individual's genotype. EPIC (850k) chip platform for DNA methylation patterns will be used to measure these changes.
Measured: 6 months
Secondary outcomes (11)
Effects of Availom on inflammation
Blood will be analysed for markers of inflammation (CRP and cytokines; eg TNFa, IL6), using commercially available immunoassays all measurements will be in pg/ml.
Measured: 6 months
Effects of Availom on plasma lipids
Changes in plasma lipids will be measured; Omega-3 fatty acids and their metabolites, especially eicosanoids, resolvins D1, EPA/DHA levels, LDL-cholesterol. Commercially available immunoassays will be used. The unit of measurement for all measures will be pg/ml.
Measured: 6 months
Effects of Availom on in vitro neurogenesis markers
Serum obtained from participants at baseline and end point visit will be used to treat hippocampal progenitor cells in an established in vitro model of hippocampal neurogenesis, developed by the Thuret lab at KCL. This will be an entirely in vitro experiment using only the serum samples from this trial's participants.
Following cell culture and immunocytochemistry, this assay provides information on the neurogenic potential of each individual. Neurogenic potential is measured as percentage cells positive for SOX2/ NESTIN/ KI67/ CC3 /DCX and MAP2.
The values obtained from cells treated with endpoint samples will be compared to values obtained from cells treated with baseline samples for each individual to control for inter-individual differences allowing us to use this set up to establish if 6 months of availom can alter an individuals neurogenic potential.
Measured: 6 months
Effects of Availom on brain-derived neurotrophic factor
Levels of BDNF has been shown to be a reliable index as biomarker for assessing the effectiveness of Omega-3 supplements in improving brain function.
Measured: 6 months
Effect of Availom on microbiome changes
DNA will be extracted from stool samples provided by study subjects and the microbial composition determined following next-generation sequencing to assess the effect of Availom on microbial composition.
Measured: 6 months
Investigate potential moderators of the effect of Availom on microbial composition
Microbiome data obtained in outcome 7 will be analysed and correlated to (meta)data collected to identify key species linked to gut health.
Measured: 6 months
Effects of Availom on cognition as measured by use of MoCA
As measured by Montreal Cognitive Assessment (MoCA). MOCA scores range between 0 and 30 points, with a higher score indicating higer cognitive function.
Measured: 6 months
Effects of Availom on cognition as measured by use of CERAD
As measured by the word list memory test from the Consortium to establish a registry for Alzheimer's disease (CERAD) neuropsychological battery. The same list is presented in a different order three times and the participant is asked to recall as many words as possible. The maximum number of correct responses is 10 for each trial with a maximum score of 30.
Measured: 6 months
Effects of Availom on muscle function as asessed by TUG
As measured by the Timed Up and Go test (TUG)
Measured: 6 months
Effects of Availom on muscle function as assessed by grip strength
As measured by testing grip strength with a dynamometer
Measured: 6 months
Effects of genotype on association between Availom and genotype
Genotype of saliva samples will be analysed using Ilumina Infinium Global Screening Array the effect of different genotypes will be assessed as a potential moderators of the association between availom and DNA methylation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start8 Dec 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double-blind placebocontrolled, paralell-group trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Evonik Industries AG
- Responsible party
- Sponsor
- Investigators
- Dag Aarsland, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150261
- Sponsor's protocol ID
- AvailOm
- Status last verified
- May 2024
- First submitted
- 7 Sep 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Effects of a New Omega-3 Fatty Acid-based Supplement on Clinical and Biological Markers of Healthy Ageing
- ClinicalTrials.gov ID
- NCT06150261
- Acronym / sponsor ID
- AvailOm
- Conditions
- Healthy Aging, Ageing Well
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Evonik Industries AG
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised, double-blind placebocontrolled, paralell-group trial
| Arm | Type | Receives |
|---|---|---|
| AvailOm | Experimental | Dietary Supplement: AvailOmAvailom capsules will be administered orally in a dose of 5 capsules/day per individum for a total of 6 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsules matching AvailOm will be administered orally in a dose of 5 capsules/day per individum for a total of 6 months. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvailOm5 capsules taken once daily with main meal | Dietary supplement | AvailOm |
| Placebo5 capsules taken once daily with main meal | Dietary supplement | Placebo |
Primary outcome
Effects of Availom on DNA methylation
Time frame: 6 months
Effects of Availom on DNA methylation will be measured by a novel saliva-based method and correlated with the individual's genotype. EPIC (850k) chip platform for DNA methylation patterns will be used to measure these changes.
11 secondary outcomes
Effects of Availom on inflammation
Time frame: 6 months
Effects of Availom on plasma lipids
Time frame: 6 months
Effects of Availom on in vitro neurogenesis markers
Time frame: 6 months
Effects of Availom on brain-derived neurotrophic factor
Time frame: 6 months
Effect of Availom on microbiome changes
Time frame: 6 months
Investigate potential moderators of the effect of Availom on microbial composition
Time frame: 6 months
Effects of Availom on cognition as measured by use of MoCA
Time frame: 6 months
Effects of Availom on cognition as measured by use of CERAD
Time frame: 6 months
Effects of Availom on muscle function as asessed by TUG
Time frame: 6 months
Effects of Availom on muscle function as assessed by grip strength
Time frame: 6 months
Effects of genotype on association between Availom and genotype
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dag Aarsland, PhD principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AvailOm in people with Healthy Aging and Ageing Well, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dag Aarsland, PhD (+47 51515062, dag.arsland@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Availom on DNA methylation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.