Clinical Evaluation of a Specific Enteral Diet for Diabetics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Vegenat, S.A..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Vegenat, S.A.
ClinicalTrials.gov Identifier:
NCT01247714
First received: November 23, 2010
Last updated: June 21, 2012
Last verified: November 2010
  Purpose

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).


Condition Intervention
Hyperglycemia
Diabetics
Metabolic Syndrome
Dietary Supplement: T-Diet plus Standard
Dietary Supplement: T-Diet plus Diabet NP
Dietary Supplement: Glucerna
Dietary Supplement: Novasource

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of a Specific Enteral Diet for Diabetics.A Randomised Cross-Over Study

Resource links provided by NLM:


Further study details as provided by Vegenat, S.A.:

Primary Outcome Measures:
  • Nutritional status and Glycaemia [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    • 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


Enrollment: 43
Study Start Date: September 2009
Estimated Study Completion Date: March 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: GLCR
Dietary Supplement: Novasource
Complete high protein diet for diabetic patients and hyperglycemic
Other Name: 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 Name: 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 Name: 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 Name: GLCR
Dietary Supplement: Novasource
Complete high protein diet for diabetic patients and hyperglycemic
Other Name: NVS

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).

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247714

Locations
Spain
Department of Biochemistry and Molecular Biology II. University of Granada
Granada, Spain, 18014
Sponsors and Collaborators
Vegenat, S.A.
Investigators
Principal Investigator: Ángel Gil, PhD Departament of Biochemistry and Molecular Biology II. University of Granada
  More Information

No publications provided

Responsible Party: Vegenat, S.A.
ClinicalTrials.gov Identifier: NCT01247714     History of Changes
Other Study ID Numbers: VEGENAT-DIABET NP UGR, DIABET NP 2009-PROYECTO CDTI
Study First Received: November 23, 2010
Last Updated: June 21, 2012
Health Authority: Spain: Ministry of Health and Consumption
Spain: Comité Ético de Investigación Clínica

Keywords provided by Vegenat, S.A.:
T-Diet plus Diabet NP
Diabetic
Enteral Nutrition
Glycaemic response
Metabolic Syndrome
Insulin resistance
Lipidic profile

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Hyperglycemia
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes
Phentermine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014