Clinical Evaluation of a Specific Enteral Diet for Diabetics

Clinical Evaluation of a Specific Enteral Diet for Diabetics.A Randomised Cross-Over Study

The hypothesis of the proposed trials is that the regular intake of a specific diet designed for enteral nutrition of type 2 diabetic patients results into a better nutritional status. Thus, the aim of the study is to scientifically evaluate the healthy effects of the administration of an enteral complete diet for diabetic patients (T-Diet plus Diabet).

Study Overview

• Status: Unknown
• Conditions: Hyperglycemia; Metabolic Syndrome; Diabetics
• Intervention / Treatment: Dietary supplement: T-Diet plus Standard; Dietary supplement: T-Diet plus Diabet NP; Dietary supplement: Glucerna; Dietary supplement: Novasource

Detailed Description

This new complete diet has been carefully formulated, and incorporates functional ingredients based on:

1. A good gastrointestinal and metabolic tolerance of the product.
2. Beneficial outcomes in the nutritional status.
3. A good control of the glycaemic response and the lipidic profile, allowing an improvement of metabolic syndrome and insulin resistance indicators and hunger-satiety regulation.

The experimental enteral product is a complete diet that includes, as carbohydrates, high-molecular maltodextrin, resistant maltodextrin, fructooligosaccharides and cellulose, and does not contain added fructose. Indeed, this product contains eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18014
    • Department of Biochemistry and Molecular Biology II. University of Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diabetic Subjects older than 55 years.
• Male or female
• Requirement of total enteral nutrition (TEN) during at least 3 months.
• Under medical supervision.
• Voluntary informed consent for participation.

Exclusion Criteria:

• Unstable clinical situation
• Fatal illness
• Patients treated with lipidic drugs
• Refusal to participate in the study or being enrolled in other clinical trials.
• Social or humanitarian reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; The group 1 will receive the experimental product T-Diet plus Diabet NP for the first month followed by a reference diet corresponding to a current marketed product (Glucerna SR, Abbott) for the second month, then the patients will receive a control product non specific for diabetic patients (T-Diet plus Standard)for the third month, and finally a specific diet for diabetic patients (Novasource, Nestlé Healthcare Nutrition)for the fourth month.	Dietary supplement: T-Diet plus Standard; T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.; Other Names: PLUS STD; Dietary supplement: T-Diet plus Diabet NP; T-Diet plus Diabet NP is a complete balanced oral nutrition supplement, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.; Other Names: DIABET NP; Dietary supplement: Glucerna; GLUCERNA 1.0 CAL is a reduced-carbohydrate, modified-fat, fiber-containing formula clinically shown to blunt blood-glucose response in patients with abnormal glucose tolerance.; Other Names: GLCR; Dietary supplement: Novasource; Complete high protein diet for diabetic patients and hyperglycemic; Other Names: NVS
Active Comparator: Group 2; The group 2 will receive a reference diet corresponding to a current marketed product (Glucerna SR, Abbott)for the first month, followed by the experimental product T-Diet plus Diabet NP for the second month, then the patients will receive a specific diet for diabetic patients (Novasource, Nestlé Healthcare Nutrition)for the third month, and finally a control product non specific for diabetic patients (T-Diet plus Standard)for the fourth month	Dietary supplement: T-Diet plus Standard; T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.; Other Names: PLUS STD; Dietary supplement: T-Diet plus Diabet NP; T-Diet plus Diabet NP is a complete balanced oral nutrition supplement, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.; Other Names: DIABET NP; Dietary supplement: Glucerna; GLUCERNA 1.0 CAL is a reduced-carbohydrate, modified-fat, fiber-containing formula clinically shown to blunt blood-glucose response in patients with abnormal glucose tolerance.; Other Names: GLCR; Dietary supplement: Novasource; Complete high protein diet for diabetic patients and hyperglycemic; Other Names: NVS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status and Glycaemia	Evaluation of the nutritional status of diabetic patients fed the T-Diet Plus Diabet NP in comparison with the reference and the control diet.; Evaluation of glycaemia and glycosylated hemoglobin	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemicals parameters measure	Confirmation of gastrointestinal tolerance of the product; To assess changes in glycaemic response and lipidic profile in theses patients in relation with the diet, including parameters characteristic of metabolic syndrome, insulin resistace and hunger-satiety mechanism.; To analyse changes of incretins and gastrointestinal peptides levels.; To compare inflammatory and endothelial damage markers related with cardiovascular morbidity.; Genotyping and gene expression analysis of genes related with diabetes and insulin resistance	9 months

Collaborators and Investigators

• Sponsor: Vegenat, S.A.
• Investigators: Principal Investigator: Ángel Gil, PhD, Departament of Biochemistry and Molecular Biology II. University of Granada

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2014
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: November 23, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2014
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Insulin resistance; Diabetic; Metabolic Syndrome; Enteral Nutrition; Glycaemic response; Lipidic profile; T-Diet plus Diabet NP
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Hyperglycemia; Metabolic Syndrome; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Appetite Depressants; Anti-Obesity Agents; Central Nervous System Stimulants; Sympathomimetics; Phentermine
• Other Study ID Numbers: VEGENAT-DIABET NP UGR; DIABET NP 2009-PROYECTO CDTI (Other Identifier: VEGENAT, S.A.)