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Healthy Ageing Clinical Trials

Scientific Background

The world’s population is ageing; according to data from World Population Prospect the number of older persons (i.e. those aged 60 years or over) is expected to more than double by 2050 rising from 962 million globally in 2017 to 2.1 billion in 2050.  Therefore, ensuring healthy ageing is vital to global health.

Healthy Ageing is about maintaining the functional ability that allows you to do the things you value. This means preserving both your physical and mental capacity as you age [WHO]

Nutrition plays a significant role in determining the health and well-being of older people. Improved nutrition can be achieved by making improvements in the nutrient density of food, particularly vitamins and minerals and maintaining intakes of energy and proteins. Attention to the nutrition of older people can help reverse patterns of malnutrition in older people that increase care dependency and decrease intrinsic capacity.

Exercise also plays an important role in the physical, cognitive and social health of the elderly. For instance, ageing is characterized by a loss of homeostatic mechanisms which on many occasions leads to the development of frailty. Hence frailty is one of the major geriatric syndromes and leads to poorer outcomes in terms of disability, hospitalisation and premature death. Exercise is proposed to delay the onset of frailty in older persons thus increasing health and life span. In addition, combined with cognitive training, exercise has also been linked to improved cognitive functions and functional status of older adults with and without cognitive impairment.

Going forward, there needs to be well designed clinical trials of dietary and exercise interventions that are of sufficient size and duration to understand the functional benefits of potential nutritional and physical activity choices for the elderly. These trials should include mechanistic components focused on the hallmarks of biologic aging to link biologic changes to any functional benefits that might be observed.

 

What Atlantia offer

Atlantia Food Clinical Trials has extensive experience in conducting human dietary intervention studies across a variety of health areas related to ageing including sarcopenia, cognition (mood, memory, mental acuity), physical performance, osteoarthritis and osteopenia.

We have conducted trials on a variety of investigational food products (IP), ranging from probiotics, prebiotics, fibers and a range of other substrates, including botanical extracts, minerals, vitamins and peptides.

We have a large database of healthy subjects striated across gender and age, and also a considerable patient database.

Our expert research team will work with sponsor(s) to design and conduct a study most suitable for their IP, agreeing and applying the most suitable diagnostics. We can statistically power your study to ensure that your objectives are achieved and reported in accordance with EFSA  and FDA guidelines.

Measurements & Indications

Healthy Ageing Analysis (SUBJECTIVE)
Physical Activity: Physical Activity Scale for the Elderly (PASE)
Cognitive Function: standardised cognitive test battery e.g. Cambridge Neuropsychological Test Automated Battery (CANTAB); mini-mental state examination (MMSE)
Anxiety & Sleep Quality: Hamilton Anxiety Rating Scale (HAM-A); Geriatric Depression Scale
Dietary Analysis: FFQ, 24 hour recall, 3 day diary
Healthy Ageing Analysis (OBJECTIVE)
Cardiovascular Health: Blood Pressure (BP); Ambulatory BP; Endothelial function e.g. flow-mediated dilation (FMD)
Gastrointestinal Health: GI transit; bowel function; dysphagia; microbiome diversity
Physical Activity & performance: hand grip strength; chair stand; 6 min walking test; agility (chair seat and reach); 2 minute step test
Body composition measurements e.g. % lean muscle, bone density, using DEXA scan; Biometric & Anthropometric Measurements: resting heart rate, weight, muscle circumference
Biological Sample Analysis: inflammatory biomarkers; plasma essential and non-essential amino acids, total protein, albumin, serum and urinary urea (sarcopenia and amino acid uptake studies); serum iron, transferrin saturation, iron binding capacity, ferritin levels (anaemia & iron uptake studies); plasma and salivary cortisol, IgA, tryptophan (stress indicators), creatinine; glucose; serum triglyceride; omega-3 fatty acids; oxidative stress measurements

 

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