Study About Adherence and Tolerance of an Oral Nutritional Supplement (ONS) Specific for Diabetic Patient.

The subject assumes a position with arms crossed at the chest. The perimeter is taken at the narrowest level, between the lower costal margin (10th rib) and the iliac crest. The anthropometrist stands in front of the subject, who has his arms slightly abducted, to allow the waist to run around the abdomen. Values greater than 80 centimeters (women) and 94 centimeters (men) are considered a risk for cardiovascular diseases.

It is the relationship between the individual's body weight (kg) and height (m) squared: Weight/Height2. Values greater than 24,9 kg/m2 are considered as overweight

Changes in the percentage (%) of Extracellular Water via bioelectrical impedance

Changes in the percentage (%) of Intracellular Water via bioelectrical impedance

Changes in the percentage (%) of Total Body Water via bioelectrical impedance

Changes in the phase angle (grades) via bioelectrical impedance

Changes in the percentage (%) of Body Cell Mass via bioelectrical impedance

Changes in serum albumin concentration. The normal range is 3.4 to 5.4 g/dL (34 to 54 g/L)

Changes in serum prealbumin concentration. Normal results in adults range between 15 and 36 milligrams per deciliter (mg/dL) or 150 and 360 milligrams per liter (mg/L)

Changes in fasting serum glucose concentration. The levels are between 74 and 100 mg/dL.

Changes in serum insulin levels. A basal insulin level between 5-25 IU/ml is considered normal, higher than 30 U/ml suggests insulin resistance. Insulin maximum value 6 to 8 times the basal value.

Changes in the percentage of HbA1c. An HBA1c level of less than 5.7% is normal, 5.7 to 6.4% indicates prediabetes, and 6.5 or greater indicates diabetes. Within the prediabetes range (5.7 to 6.4%), the higher the A1c value, the greater the risk of developing type 2 diabetes

Changes in total cholesterol concentration. A concentration less than 200 mg/dL is recommended, with a normal upper limit between 200 and 239 mg/dL. Measurements above 240 mg/dL indicate excessive consumption through diet or familial hypercholesterolemia

Changes in triglyceride concentration. Normal values are less than 150 mg/dL; the upper limit is between 150 and 199 mg/dL. However, values between 200 and 499 mg/dl are considered high or very high (above 500 mg/dl).

Changes in LDL-cholesterol concentration. Optimal levels are less than 100 mg/dL, although concentrations between 100 and 129 mg/dL are considered almost optimal. The upper limit of normal is between 130 and 159. Values between 160 and 189 mg/dL are considered high, and those above 190 mg/dL as very high.

Changes in HDL-cholesterol concentration. Values above 60 mg/d Lare considered a protective factor against cardiovascular diseases.Concentrations between 40 and 59 mg/dL are correct, while values below 40 mg/dL are one of the main risk factors for cardiovascular disease.

Changes in creatinine concentration. Normal values are 0.7 to 1.3 mg/dL (61.9 to 114.9 µmol/L) for men and 0.6 to 1.1 mg/dL (53 to 97.2 µmol/L) for women. Women often have lower creatinine levels than men, due to less muscle mass.

Changes in urate concentration. Normal values are between 3.5 and 7.2 milligrams per deciliter (mg/dL).

Questionnaire on Consumption Adherence to the Mediterranean Diet. The questionnaire consists of 14 questions with a variable score on different aspects of the diet and the Mediterranean pattern. A score less than 9 indicates poor adherence, while a score of 9 or more points indicates good adherence.

Questionnaire to find out the nutritional and dietary habits of each participant. The volunteer will write down all the food and drinks ingested over 1 day (24 hours). The answers will allow calculating the total amount of food consumed and calories ingested. In addition, the data will be evaluated quantitatively and qualitatively, classifying the diet in terms of diversity and balance following the recommendations of the Spanish Society of Community Nutrition (SENC 2016).

The questionnaire is divided into 4 categories of questions depending on the type of activity for which information is requested (vigorous, moderate, walking, sedentary). The quantitative results allow calculating the TOTAL Energy Metabolism Rate (MET) x minute/week for each subject. Qualitative results categorize the volunteers' physical activity into low activity (1), moderate activity (2), or vigorous activity (3).

The EuroQol 5D quality of life questionnaire will be used. The questionnaire is divided into two parts. In the first, questions are asked regarding mobility, personal care, daily activities and the presence of pain, discomfort, anxiety or depression. In the second part, the patient must use a visual analog health scale from 1 to 10 to indicate their subjective state of health, with 0 being the worst state of health imaginable and 10 being the best state of health imaginable.

The GSRS is a specific instrument for the assessment of digestive symptoms that includes 15 items grouped into 5 blocks based on the different gastrointestinal symptoms. The 5 groups of symptoms represent reflux, abdominal pain, indigestion, diarrhea and constipation. It has a score based on a Likert-type scale of 7 degrees, where 1 represents the most positive option and 7 the most negative.

The taste and olfactory sensory perception of the participants for the products will be evaluated by means of a questionnaire using Visual Analogue Scales (VAS) with a score of 0 to 10.