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

NCT06150261 | Recruiting

• 1 other identifier: AvailOm
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging; Ageing Well

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (11)

• Effects of Availom on inflammation

  6 months

• Effects of Availom on plasma lipids

  6 months

• Effects of Availom on in vitro neurogenesis markers

  6 months

• Effects of Availom on brain-derived neurotrophic factor

  6 months

• Effect of Availom on microbiome changes

  6 months

Study Arms (2)

AvailOm

EXPERIMENTAL

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

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.

Dietary Supplement: Placebo

Interventions

AvailOm DIETARY_SUPPLEMENT

5 capsules taken once daily with main meal

AvailOm

Placebo DIETARY_SUPPLEMENT

5 capsules taken once daily with main meal

Placebo

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Helse Stavanger HF: lead
• Evonik Industries AG: collaborator

Study Sites (1)

Stavanger Universitetssjukehus

Stavanger, Norway

RECRUITING

Study Officials

• Dag Aarsland, PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dag Aarsland, PhD

CONTACT

+47 51515062; dag.arsland@sus.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised, double-blind placebocontrolled, paralell-group trial

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: November 29, 2023
• Study Start: December 8, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 14, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)