HyperglycemiaNCT01247714
Clinical Evaluation of a Specific Enteral Diet for Diabetics
A study testing T-Diet plus Standard, T-Diet plus Diabet NP and Glucerna in people with Hyperglycemia and Diabetics, run by Vegenat, S.A. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hyperglycemia, Diabetics, Metabolic Syndrome
- What is being tested?
- T-Diet plus Standard, T-Diet plus Diabet NP and Glucerna
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2009to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Biochemistry and Molecular Biology II. University of Granada
Granada, Granada, 18014
About this study
Official title: 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).
Read the 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).
- Conditions
- Hyperglycemia, Diabetics, Metabolic Syndrome
- Being tested
- T-Diet plus Standard, T-Diet plus Diabet NP, Glucerna, Novasource
- Keywords
- T-Diet plus Diabet NP, Diabetic, Enteral Nutrition, Glycaemic response, Metabolic Syndrome, Insulin resistance, Lipidic profile
- Medical subject headings
- Hyperglycemia, Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Diet plus StandardDietary supplement
Also called PLUS STD
T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.
T-Diet plus Diabet NPDietary supplement
Also called 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.
GlucernaDietary supplement
Also called GLCR
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.
NovasourceDietary supplement
Also called NVS
Complete high protein diet for diabetic patients and hyperglycemic
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 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. Receives: Dietary Supplement: T-Diet plus Standard; Dietary Supplement: T-Diet plus Diabet NP; Dietary Supplement: Glucerna; Dietary Supplement: Novasource |
| Group 2 | Active comparator | 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 Receives: Dietary Supplement: T-Diet plus Standard; Dietary Supplement: T-Diet plus Diabet NP; Dietary Supplement: Glucerna; Dietary Supplement: Novasource |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Secondary outcomes (1)
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2014
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vegenat, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ángel Gil, PhD, Principal investigator, Departament of Biochemistry and Molecular Biology II. University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247714
- Sponsor's protocol ID
- VEGENAT-DIABET NP UGR
- Other IDs
- DIABET NP 2009-PROYECTO CDTI
- Status last verified
- Nov 2010
- First submitted
- 23 Nov 2010
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Specific Enteral Diet for Diabetics.A Randomised Cross-Over Study
- ClinicalTrials.gov ID
- NCT01247714
- Acronym / sponsor ID
- VEGENAT-DIABET NP UGR
- Conditions
- Hyperglycemia, Diabetics, Metabolic Syndrome
- Keywords
- T-Diet plus Diabet NP, Diabetic, Enteral Nutrition, Glycaemic response, Metabolic Syndrome, Insulin resistance, Lipidic profile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Vegenat, S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (estimated)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Dietary Supplement: T-Diet plus Standard, Dietary Supplement: T-Diet plus Diabet NP, Dietary Supplement: Glucerna, Dietary Supplement: NovasourceThe 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. |
| Group 2 | Active comparator | Dietary Supplement: T-Diet plus Standard, Dietary Supplement: T-Diet plus Diabet NP, Dietary Supplement: Glucerna, Dietary Supplement: NovasourceThe 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-Diet plus StandardAlso: PLUS STDT-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition. | Dietary supplement | Group 1, Group 2 |
| T-Diet plus Diabet NPAlso: DIABET NPT-Diet plus Diabet NP is a complete balanced oral nutrition supplement, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. | Dietary supplement | Group 1, Group 2 |
| GlucernaAlso: GLCRGLUCERNA 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. | Dietary supplement | Group 1, Group 2 |
| NovasourceAlso: NVSComplete high protein diet for diabetic patients and hyperglycemic | Dietary supplement | Group 1, Group 2 |
Primary outcome
Nutritional status and Glycaemia
Time frame: 9 months
* 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
1 secondary outcome
Biochemicals parameters measure
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
Related trials for Hyperglycemia
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ángel Gil, PhD principal investigator
Departament of Biochemistry and Molecular Biology II. University of Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-Diet plus Standard, T-Diet plus Diabet NP and Glucerna in people with Hyperglycemia and Diabetics, run by Vegenat, S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status and Glycaemia (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.