Glycemic Index Evaluation of a Hypercaloric/High-protein Nutritional Supplement in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      Diabetes mellitus (DM) is a chronic disease with a higher prevalence in the world population,
      especially in the elderly population.The main consequence of the alteration of DM is the
      increase in blood glucose levels. When the concentration reaches levels above 180-200 mg / dl
      after ingestion, the following symptoms appear: polyphagia, polydipsia, polyuria and weight
      loss. Diet, on some occasions, is the only therapy necessary. The commercialized formulas
      considered as "standard", have a high content of carbohydrates with a high glycemic index
      (approximately 50%) and low in lipids (30-35%) and do not usually contain fiber. This type of
      liquid formulations seem to increase the insulin and glycemic response in healthy people, and
      to a greater extent in patients with DM, compared to what would cause a similar intake of
      nutrients in a mixed diet.

      All diabetic formulas provide carbohydrates with low glycemic index. They are made from
      starches, with a variable contribution of fructose, which in all cases should be less than
      20% of the total caloric intake, due to its lower glycemic index, its greater sweetening
      power and its entry into the cell is insulin-independent. However, it is necessary to
      determine the glycemic index of the new specific formulas for this population through
      clinical trials.Based on these initial facts, researchers consider it appropriate to carry
      out a pilot study to evaluate the glycemic index of a Oral Nutritional Supplement (ONS)
      especially indicated for diabetic people in a group of healthy people.
    

Detailed description: 
      Diabetes mellitus (DM) is a chronic disease with a higher prevalence in the world population,
      especially in the elderly population. It is considered one of the main health problems
      worldwide. Taking into account the aging of the population, the increase in obesity and the
      sedentary lifestyle, the World Health Organization (WHO) predicts that disease incidence in
      developed countries will increase. In Spain, DM affects 6% of the population; being more
      frequent type 2 DM in the elderly population. Nearby 20% of the Spanish population> 60 years
      of age suffers from it. In type 2 DM there is resistance to insulin, in addition to a deficit
      in its production. Concerning hyperglycemia, both phenomena must be present.

      The main consequence of the alteration of DM is the increase in blood glucose levels. When
      the concentration reaches levels above 180-200 mg / dL after ingestion, the following
      symptoms appear: polyphagia, polydipsia, polyuria and weight loss. These short-term symptoms
      are the most common. Diabetes prevention is based on an integrated holistic approach based on
      healthy eating, daily physical exercise and adequate health education. To achieve a proper
      balance between these three pillars, patient collaboration is required.

      Most of cases just need diet as the only therapy needed. The importance of weight loss is
      highlighted, since approximately 80% of patients with DM 2 have a BMI> 25 kg / m2. The main
      objective of the diet is to achieve normal blood glucose levels both in the fasting state and
      in the postprandial phase. Blood pressure and lipid control are also important. However,
      elderly diabetic patients are more likely to suffer from malnutrition associated with the
      disease, with a higher prevalence than in the general population. The prevalence of the
      diabetic patient referring to the hospital setting ranges between 5-11%. However, extracted
      data from hospital discharges rise up to 20%, if medical records are considered.

      The main indications for enteral nutrition (EN) application, according to data from 2001,
      were neurological alterations (43.3%) and neoplasms (39%), which are frequent pathologies in
      elderly patients. Regarding hospitalized patients, between 5-10% receive some type of
      nutritional support. When prevalence rate of diabetic patients is applied to this population
      group, 1-2% of hospitalized diabetic patients are prescribed with some type of nutritional
      supplement. Malnutrition in diabetic patients worsens if the supplements are not correctly
      tolerated, leading to a worse diagnosis due to the difficulty in healing and the greater
      propensity for infections, leading to longer hospital stays.

      The commercialized formulas considered as "standard", have a high content of carbohydrates
      with a high glycemic index (approximately 50%) and low lipids (30-35%) and do not usually
      contain fiber. This type of liquid formulations seems to increase the insulin and glycemic
      response in healthy people, and to a greater extent in patients with DM, compared to what
      would cause a similar intake of nutrients in a mixed diet. It seems that when ingesting a
      formula with a low carbohydrate content and high content of monounsaturated fatty acids, the
      postprandial glycemic response depends fundamentally on the total carbohydrate content,
      downplaying the source (starch or fructose) or even the addition or type of fiber. Therefore,
      it seems that as the carbohydrate content increases, the lipid content could contribute to
      the attenuation of the glycemic response. However, more comparisons are needed between
      specific diabetes diets (high, moderate, and low fat) with each other and with other standard
      diets (with and without fiber).

      All diabetic formulas provide carbohydrates with low glycemic index. They are made from
      starches, with a variable contribution of fructose. Fructose should be less than 20% of the
      total caloric intake in all cases, due to its lower glycemic index, its greater sweetening
      power and its entry into the cell as insulin-independent. However, it is necessary to
      determine the glycemic index of the new specific formulas for this population through
      clinical trials.

      Based on these initial facts, researchers consider to carry out a pilot study to evaluate the
      glycemic index of a Oral Nutritional Supplement (ONS) especially indicated for diabetic
      patients in a group of healthy people.
    

Intervention name(s): Oral Nutritional Supplement; Glucose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants must consume 416 mL of ONS FontActiv® DiaBest HP / HC vanilla flavor. A maximum time of 10 min will be given to consume the entire product.; Participants must consume a 50 g glucose solution in 10 min to obtain the ares under the curve (AUC) data from glucose consumption
Other intervention name(s): Experimental
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossed, controlled and randomized clinical trial
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: diabetes; oral nutritional supplement; glycemic index; healthy population