NCT05488210

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

Study to Evaluate the Effect of Consuming an Oral Nutritional Supplement (ONS) Specifically for Diabetic Patients on Adherence and Gastrointestinal Tolerance and Nutritional Status in Patients With DM2 and Malnutrition

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Diabetes Mellitus (DM) is one of the most prevalent chronic diseases today, it is reaching epidemic proportions, mainly caused by the increase in type 2 diabetes (DM2).The foundation of any hypoglycemic treatment is based on a healthy diet, daily physical exercise and adequate health education with the collaboration of the patient. Diet is sometimes the only necessary therapy since approximately 80% of patients with DM2 are usually overweight, what is mainly wanted with diet is to achieve normal blood glucose levels both fasting and in the postprandial phase. This diet must be a varied diet combining foods from the different food groups; however, carbohydrate control must be one of the key strategies for glycemic control. Currently, there is also talk of the concept of disease-related malnutrition (DRM). DRM is malnutrition associated with a pathological state, with the presence of inflammation being a key factor in determining its etiology. This inflammation can be chronic or acute depending on the type of pathology. Therefore, the fiber and carbohydrate composition of oral nutritional supplements are important for glycemic control, so a study is proposed to evaluate the effect of consuming a ONS hypercaloric/high-protein (HC/HP) with fiber, and enriched in calcium, Vitamin D and DHA on adherence and tolerance of the product and nutritional status in patients with DM2 and malnutrition.

Detailed description

Longitudinal, prospective exploratory study, to evaluate the effect of consuming an oral nutritional supplement (ONS) HC/HP with fiber, and enriched in calcium, Vitamin D and Docosahexaenoic acid (DHA) on adherence and tolerance of the product and nutritional status in patients with DM2 and malnutrition, in a period of 60 days. Twenty-four volunteers will be recruited at the La Paz University Hospital of Madrid. Participants should meet the next inclusion criteria: men and woman enter 18 and 85, with DM2 previously diagnosed and controlled, with malnutrition diagnosed according to the Global Leadership Initiative on Malnutrition (GLIM) criteria, who require taking ONS, willing to consume the ONS during the study and adequate cultural level and understanding of the clinical study. Follow up will include 4 individualized visits.

Conditions

• Diabetes
• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	FontActiv DiaBest HP/HC	Daily intake of two FontActiv DiaBest HP/HC during 2 months

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-12-31
• Completion: 2023-07-01
• First posted: 2022-08-04
• Last updated: 2022-08-04

Locations

1 site across 1 country: Spain