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Metabolic Health Clinical Trials

Scientific Background

Metabolism refers to the entire range of biochemical, anabolic (build-up) and catabolic (break down), processes that occur in the body and is commonly used to refer specifically to the breakdown of food and its transformation into energy. Unhealthy metabolism results in many physiological disturbances increasing the risk for cardiometabolic disease such as Diabetes, thus, metabolic health is of major importance for every human being.

Being “metabolically healthy” is often defined by less than two metabolic abnormalities among the four components of Metabolic Syndrome (independent of having central obesity); that is, raised blood pressure, raised fasting blood glucose, raised triglycerides and reduced high density lipoprotein (HDL) cholesterol. Whilst central (abdominal) obesity, easily assessed using waist circumference, is a prerequisite risk factor for Metabolic Syndrome, the observation that some obese individuals have a favourable metabolic profile has led to the notion of ‘metabolically healthy obesity’. Thus, for a comprehensive assessment of the metabolic health of a population additional metabolic measurement such as (but not limited to) insulin resistance, subclinical inflammation and visceral obesity are recommended.

What Atlantia offer

Atlantia Food Clinical Trials has extensive experience in conducting human dietary intervention studies in metabolic health and diseases (metabolic syndrome). Indications include: blood pressure, triglycerides, BMI, cholesterol and blood sugar control. Assesments include DXA, Oral Glucose Tolerance Test (OGTT) and Continuos Glucose Monitoring (CGM).

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

Metabolic Health Measurements
Indication Measurements
Abnormal Body Fat Distribution Body Composition: DEXA or Tanita anthropometric measurements (waist circumference, calliper skin fold thickness, body composition analyser (bioimpedance); Adipose tissues biomarkers: leptin, adiponectin; Central fat: CT/MRI; Liver fat content: MRS
Atherogenic dyslipidaemia Cholesterol: total, LDL, HDL; Apolipoprotein A1 & B, Omega 3 fatty acids EPA/DHA, conjugated linoleic acid
Vascular Dysregulation Systolic/diastolic blood pressure (BP); Ambulatory BP; Endothelial function: flow mediated dilation (FMD); ACE inhibition
Inflammation High sensitivity C-reactive protein (hsCRP); Cytokines: TNF alpha, interleukin-6; Bradykinin;
Hormonal Factors Leptin, ghrelin, cholecystokinin plasma, glucagon-like peptide (GLP) -1 growth hormones, cortisol
Insulin Resistance Elevated fasting glucose: oral glucose tolerance test (OGTT); postprandial insulin; Elevated free fatty acids; HOMA-IR
Thrombosis Fibrinolytic factors (PAI-1, etc); Clotting factors (fibrinogen, etc)

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Learn more

Check our Resources on Metabolic Health