Atlantia Food Clinical Trials - Extensive experience

Atlantia Food Clinical Trials is a company based in Ireland that spun out of the APC Microbiome Institute at University College Cork in 2013. It delivers end-to-end solutions for clinical trials in functional ingredients in foods and beverages, nutraceuticals, medical foods and dietary supplements.

Over the past few years, the team at Atlantia has built a comprehensive client list that includes many of the industry's biggest names. Running all of its studies in accordance with ICH-GCP, the company ensures that its clients are receiving the highest industry standards for a clinical programme.

Atlantia has extensive clinical expertise in many health areas and, together with a clinical team of physicians, project managers, research nurses, nutritionists, certified sports trainers, lab researchers and recruitment officers, it expertly delivers tailored human intervention studies in specific functional ingredients. The company has a subject database of healthy volunteers, the elderly, subjects with mild GI conditions and athletes, which is now approaching 10,000 people.

Atlantia has a highly flexible structure, with expertise in running acute, observational and intervention studies across a broad spectrum of functional food and beverage categories, such as dairy, cereal, probiotic, different protein forms, vitamins/minerals, plant or marine extracts and medical foods. The company can provide support to projects anywhere from preclinical research, product development and packaging, to managing all aspects of the trial - including protocol design, recruitment, study execution, sample and data analysis, statistics, and report/dossier preparation.

Digestive health

Atlantia has extensive expertise in looking at digestive health in a variety of populations including infants
and the elderly, and in patient groups such as those with
IBS, IBD and constipation. The company can measure:

  • bowel function: transit time (X-ray with radiopaque pellets), frequency of bowel movement, faecal bulk and stool consistency (Bristol stool scale)
  • gastrointestinal pain or discomfort: validated questionnaires on bloating, abdominal pain or cramping, borborygmi (rumbling), symptom diaries
  • food diaries: including nutritional assessments and validated questionnaires
  • integrity of the intestinal lining/gut permeability: lactulose-mannitol test, changes to inflammatory cytokines or to biomarkers of GI function in blood or urine
  • digestion/absorption of nutrients: blood protein, free amino acid, nitrogen, urea levels, triglycerides, cholesterol and fatty acids, as well as vitamin status, glucose/insulin levels or iron absorption
  • digestive conditions: IBS, ulcerative colitis or Crohn's disease.

The company can also monitor changes in gut microbiota induced by diet using various methods such as PCR, microbiology or pyrosequencing, radiological imaging, endoscopy, colonoscopy, gastroscopy or biopsy.

Mental and cognitive health

Through its close working relationship with psychiatrists, neuropharmacologists, gerontologists and geriatricians, Atlantia has comprehensive experience in many aspects of brain health in the healthy and elderly, in patient groups (with IBS, mild psychiatric illness or mild cognitive impairment) and in the institutionalised elderly. These include:

  • cognitive function: using a standardised cognitive test battery (CANTAB), which can test memory, attention, alertness, problem-solving; and assessing the maintenance of cognitive function or reduction in the rate of age-related cognitive decline in elderly populations, using CANTAB and validated clinical diagnosis tools
  • cognitive development in children: age-specific neurodevelopment tests
  • memory: validated psychometric tests for working memory and implicit memory
  • mood effects: variety of psychometric tests and validated questionnaires
  • psychological stress: psychometric measures using validated scales and changes in biological stress indicators (salivary and plasma cortisol, IgA, tryptophan, heart rate and sleep)
  • anxiety: validated anxiety scales such as Hamilton anxiety rating scale or sleep quality
  • IBS/visceral pain: inflammatory markers such as IL6 or CRP
  • depression: Hamilton depression scale, hospital anxiety and depression scale and Beck depression inventory.

A variety of ecologically valid stress models are available, such as Triere social stress test used in healthy volunteers.

Sports nutrition

Atlantia has experience in delivering clinical trials in the sports performance area to examine improved physical performance or endurance. In the human performance lab, it can test the whole range of physiological measurements to ascertain changes in the many data outputs.

Specifically designed training programmes and assessments for trial subjects include resistance or aerobic training, for example. Indirect calorimetry using a cosmed cardiopulmonary exercise testing (CPET) unit enables the assessment of fat and carbohydrate metabolism, energy cost of exercise, resting metabolic rate, inspiratory and expiratory lung function.

Body composition measurements can be made for lean muscle or body fat, using either DXA or bioimpedance anthropometric measures such as muscle circumference.

Cardiorespiratory fitness is measured with O2 uptake, CO2 production, maximal aerobic capacity (VO2 max) or anaerobic threshold, which can be assessed in a variety of exercise modes. Strength assessments are conducted via the Biodex System 3, which can measure isokinetic function (eccentric and concentric) and isometric strength on all the major muscle groups. Aerobic fitness, lower/upper body strength, acceleration, speed, agility, flexibility and multisprint endurance are ideally suited to the assessment of the more active individual.

Physical performance is measured with the reduced time taken to run/cycle a certain distance, increased acceleration, one repetition maximum weight lifted (1RM), jumping height, aerobic capacity/VO2 max, economy of motion, muscle fatigue, flexibility and range of motion, and abdominal strength. The endurance capacity is measured with lactate threshold and multisprint endurance.

Atlantia also has a suite of functional tests for assessing performance in the older adult. Assessments include the timed 'get up and go', chair stand, six-minute walking test and stair climb power test; tests of agility, gait speed and flexibility; tests of handgrip strength - arm curl with hand weight; tests of knee flexion/extension; and peak expiratory flow.

Cardiovascular health

The clinical trials company also has extensive experience in conducting trials in the area of cardiovascular health in several populations. It has studied:

  • lipid and lipoprotein profiles: total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, apolipoprotein A1 and B, triglycerides, omega-3 fatty acids eicosapentaenoic acid/docosahexaenoic acid, and conjugated linoleic acid
  • inflammatory/cardiovascular markers: high-sensitivity C-reactive protein, inflammatory cytokines, bradykinin, cortisol and ACE inhibition
  • blood pressure: systolic/diastolic blood pressure and ambulatory blood pressure
  • blood flow: endothelial function; for example, flow mediated dilation and AIX.

Immunity and inflammatory health

Atlantia has further experience in conducting studies within the area of immunity and inflammatory health in the region of defence against pathogens in the GI tract, women's health, measurement of immune response, allergy and autoimmunity as well as reduction of inflammation.

Healthy ageing

The company also operates in the area of conducting studies within healthy ageing. It has worked with assisted-living and free-living populations in the regions of sarcopenia, gut health, bone and joint health, cognitive function, cardiovascular health and osteoarthritis.

Nutritional health

To add to this impressive list of areas is nutritional health in populations in the areas of blood protein and amino acid uptake, triglyceride levels, vitamin and mineral status. These have been acute and long-term feeding studies. Atlantia has a new dedicated facility from which it conducts acute trials such as uptake studies, looking at proteins and supplements across a wide range of products.

Its close affiliation with the APC Microbiome Institute and Teagasc at Moorepark Research Centre, Ireland, as well as other research partners, has helped position Atlantia as an expert in the areas of digestive health, cognitive health and probiotic/prebiotic research. With a world-renowned team of clinicians and scientists, supported by Atlantia's team of project managers, nurses and nutritionists, conducting clinical studies to drug trial standards reinforces its creditability as a world leader in this field.

As a flexible and nimble company, Atlantia can offer some unique services to its clients. If your needs do not include the above, please don't hesitate to enquire specifically about your requirements and how the company can be of assistance.

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