Tolerability and Effects of a New Omega-3 Fatty Acid-based Supplement on Clinical and Biological Markers of Healthy Ageing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effects of Availom on DNA methylation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Effects of Availom on DNA methylation
时间窗: 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.
次要结局
- Effects of Availom on brain-derived neurotrophic factor(6 months)
- Effects of Availom on cognition as measured by use of MoCA(6 months)
- Effects of Availom on muscle function as assessed by grip strength(6 months)
- Effects of Availom on plasma lipids(6 months)
- Investigate potential moderators of the effect of Availom on microbial composition(6 months)
- Effects of Availom on muscle function as asessed by TUG(6 months)
- Effects of Availom on in vitro neurogenesis markers(6 months)
- Effect of Availom on microbiome changes(6 months)
- Effects of Availom on cognition as measured by use of CERAD(6 months)
- Effects of Availom on inflammation(6 months)
- Effects of genotype on association between Availom and genotype(6 months)