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Clinical Evaluation of a Specific Enteral Diet for Diabetics

Primary Purpose

Hyperglycemia, Diabetics, Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
T-Diet plus Standard
T-Diet plus Diabet NP
Glucerna
Novasource
Sponsored by
Vegenat, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperglycemia focused on measuring T-Diet plus Diabet NP, Diabetic, Enteral Nutrition, Glycaemic response, Metabolic Syndrome, Insulin resistance, Lipidic profile

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Biochemistry and Molecular Biology II. University of Granada

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 23, 2010
Last Updated
December 9, 2014
Sponsor
Vegenat, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01247714
Brief Title
Clinical Evaluation of a Specific Enteral Diet for Diabetics
Official Title
Clinical Evaluation of a Specific Enteral Diet for Diabetics.A Randomised Cross-Over Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vegenat, S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
This new complete diet has been carefully formulated, and incorporates functional ingredients based on: A good gastrointestinal and metabolic tolerance of the product. Beneficial outcomes in the nutritional status. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Diabetics, Metabolic Syndrome
Keywords
T-Diet plus Diabet NP, Diabetic, Enteral Nutrition, Glycaemic response, Metabolic Syndrome, Insulin resistance, Lipidic profile

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
T-Diet plus Standard
Other Intervention Name(s)
PLUS STD
Intervention Description
T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.
Intervention Type
Dietary Supplement
Intervention Name(s)
T-Diet plus Diabet NP
Other Intervention Name(s)
DIABET NP
Intervention Description
T-Diet plus Diabet NP is a complete balanced oral nutrition supplement, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucerna
Other Intervention Name(s)
GLCR
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Novasource
Other Intervention Name(s)
NVS
Intervention Description
Complete high protein diet for diabetic patients and hyperglycemic
Primary Outcome Measure Information:
Title
Nutritional status and Glycaemia
Description
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
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Biochemicals parameters measure
Description
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
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ángel Gil, PhD
Organizational Affiliation
Departament of Biochemistry and Molecular Biology II. University of Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biochemistry and Molecular Biology II. University of Granada
City
Granada
ZIP/Postal Code
18014
Country
Spain

12. IPD Sharing Statement

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Clinical Evaluation of a Specific Enteral Diet for Diabetics

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