Nutritional Health Clinical Trials

Scientific Background

"Nutrition is the intake of food, considered in relation to the body’s dietary needs. Good nutrition i.e. an adequate, varied and well-balanced diet, combined with regular physical activity is a cornerstone of good health. Poor nutrition can lead to reduced immunity, increased susceptibility to disease, impaired physical and mental development, and reduced productivity" [WHO]

The relationship between food, nutrition and health, is complex, dynamic, and multi-faceted. It is affected by biological, environmental, socioeconomic, cultural and behavioural factors. Global population growth, ageing population, impact of climate change, poor access to healthy foods, unhealthy lifestyles, and growing consumer demand, all present an increasing challenge. The global burden of malnutrition remains unacceptably high.

"Malnutrition in all its forms refers to undernutrition (i.e. classified by wasting, stunting, underweight), inadequate vitamins or minerals, overweight, obesity, and resulting diet-related noncommunicable diseases (NCD) such as diabetes, CVD and certain cancers" [WHO]

Globally, 1.9 billion adults are overweight or obese while 462 million are underweight; 5 million children under 5 years of age are wasted, 155 million are stunted, while 41 million are overweight or obese. Around 45% of deaths among children under 5 years of age are linked to undernutrition; these mostly occur in low- and middle-income countries [WHO factsheet on Malnutrition, 2018].

Both developed and emerging economies are facing the problem of rising levels of obesity and diet related NCDs. Proper nutrition offers one of the most effective and least costly ways to decrease the burden NCDs and their associated risk factors. High quality, multidisciplinary food and nutrition research and effective collaborations are key to improving global health.

What Atlantia offer

Atlantia Food Clinical Trials has considerable experience in conducting human clinical intervention studies to investigate the uptake of specific nutritional components. We have carried out trials on various dietary components (e.g. proteins: whey, casein, micellar forms of protein; iron) for a range of health applications (e.g. sarcopenia in the elderly, sports nutrition). We have an extensive database of volunteers including athletes, healthy and elderly. Our expert research team will work with sponsor(s) to design and conduct a study most suitable for their investigational product(s), agreeing and applying the most suitable measurements and statistically powering studies to ensure that study objectives are achieved and reported.

Measurements & Indications

Nutritional Health Analysis (SUBJECTIVE)
International Physical Activity Questionnaire (IPAQ)
WHO 5 well being index
Dietary Analysis: FFQ, 24 hour recall, 3 day diary
Nutritional Health Analysis (OBJECTIVE)
Cardiovascular & Metabolic Health: Blood Pressure (BP); Ambulatory BP; Endothelial function e.g. flow-mediated dilation (FMD); Inflammatory biomarkers: interleukine-6, C-reactive protein; blood cholesterol: total, LDL, HDL
Physical Activity & performance: aerobic capacity/VO2 max, muscle mass / strength
Body composition measurements e.g. % lean muscle, bone density, using DEXA scan; Biometric & Anthropometric Measurements: resting heart rate, weight, muscle circumference
Nutrient Analysis: plasma essential and non-essential amino acid; plasma ketones; plasma creatine and urinary nitrogen; plasma glucose, insulin, serum triglycerides, serum and urinary urea, urinary ammonia, serum and urinary protein levels, metabolomics, lipidomics, proteomics

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Check our Resources on Nutritional Health