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

NCT ID: NCT05488210

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-07-01

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Malnourished DM2 patients

Diabetic patients who present malnutrition through the GLIM criteria

FontActiv DiaBest HP/HC

Intervention Type: DIETARY_SUPPLEMENT

Daily intake of two FontActiv DiaBest HP/HC during 2 months

Interventions

FontActiv DiaBest HP/HC

Daily intake of two FontActiv DiaBest HP/HC during 2 months

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Experimental

Eligibility Criteria

Inclusion Criteria

• Men and women enter 18 and 85 years old.
• Patients with DM2 previously diagnosed and controlled.
• Patients with malnutrition diagnosed according to GLIM criteria.
• Patients who require taking ONS.
• Patients willing to consume the ONS during the study period.
• Patients with adequate cultural level and understanding of the clinical study.
• Patients who agree to voluntarily participate in the study and who give their informed consent in writing.

Exclusion Criteria

• Subjects with enteral or parenteral nutrition.
• Subjects with poorly controlled DM2.
• Subjects with dementia, eating behavior disorders, history of serious neurological or psychiatric pathology that may interfere with adherence to the consumption of the ONS.
• Subjects suffering from alcoholism or substance abuse that may interfere with adherence to the consumption of the ONS.
• Subjects with a diagnosis of kidney or liver disease under pharmacological treatment.
• Subjects with infections or any condition that interferes with nutrient digestion, absorption, metabolism, or excretion (including gastroparesis).
• Subjects with chronic gastrointestinal diseases that affect the digestion or absorption of nutrients.
• Subjects with allergies or intolerances to any of the ingredients of the formula.
• Subjects with socio-family problems that prevent them from participating in the study.
• Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundació Eurecat

OTHER

Sponsor Role: collaborator

Laboratoires Grand Fontaine S.L

UNKNOWN

Sponsor Role: collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samara Palma-Milla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital La Paz

Locations

Samara Palma Milla

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Bricia López-Plaza, PhD

Role: CONTACT

bricia.plaza@idipaz.es

917277000 ext. 442507

Facility Contacts

Samara Palma Milla, PhD

Role: primary

samara.palma@salud.madrid.org

917277000 ext. 441209

Role: backup

samara.palma@salud.madrid.org

Other Identifiers

PI-6092

Identifier Type: -

Identifier Source: org_study_id