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Nutritional Intervention With Moderately High-protein, Low-glycemic Load Products in Type-2 Diabetes Patients

NCT ID: NCT01264523

Last Updated: 2012-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-09-30

Brief Summary

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The main objective of this study is to evaluate the effects on anthropometric, glucose metabolism and lipid profile biomarkers of exchanging with high-protein, low-glycemic index products (40-30-30) the habitual breakfast, mid-morning and afternoon snacks on type-2 diabetes patients following a chronologically scheduled pattern.

Detailed Description

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Type 2 diabetes prevalence in adults has grown in the last years in many societies, accompanying the high incidence of obesity-related and other cardiovascular risk factors. Indeed, obesity is the most relevant overnutrition disease worldwide, being more dramatic than a self-esteem problem or an aesthetic issue, since it is associated to different metabolic disorders such as coronary diseases, hypertension, certain tumors, dislipidemia, biliary disorders, immunodeficiencies and insulin resistance. Different studies have shown the efficacy of low-fat diets on weight reduction, which has been associated to an improvement in overweight-related chronic pathological conditions. Additionally, a moderate increase of protein content (up to 30% of total caloric intake) in the diet and the inclusion of low-glycemic index products have been shown as a good tool for weight loss and maintenance. Recent studies have also shown the benefits of partial nutritional interventions, mainly on modifying breakfast intake, on anthropometrical and cardiovascular risk factors in overweight patients.

The study has been designed as a longitudinal nutritional intervention with two consecutive 4-week periods: from week 0 to 4, volunteers will follow their habitual diet. The second period (week 4 to 8), the volunteers' habitual breakfast, mid-morning and afternoon snacks will be substituted by 40-30-30 products, without changing any other parameter of their habitual diet or lifestyle.

Conditions

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Type-2 Diabetes Overweight

Keywords

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chrononutrition moderately high protein glycemic index type-2 diabetes overweight obesity weight management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Chronologically scheduled snacking with 40-30-30 products

Short-term analysis of the effects of the substitution of the habitual breakfast, mid-morning and afternoon snack of type-2 diabetes patients by 40-30-30 products. Longitudinal 2-period study

Intervention Type OTHER

Other Intervention Names

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Enervit, Zone diet

Eligibility Criteria

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Inclusion Criteria

* Clinically diagnosed of type-2 Diabetes
* Under dietary treatment or with Metformin
* Body Mass Index (BMI) Between 22 and 35 kg/m2

Exclusion Criteria

* BMI under 22 or over 35 kg/m2
* To follow a pharmacological treatment with other drugs but metformin
* To be already insulin-dependent
* To have other concomitant pharmacological treatments for weight loss, hormonal substitutive therapy, altered thyroid function, etc. without an stable dosage (at least three months prior the beginning of the study).
* To suffer from complications due to type 2 diabetes (microangiopathy, polyneuropathy, cardiopathy, hepatic and renal impairments, etc)
* To have a recent (less than 3 months before the beginning of the study) uncontrolled diagnostic of hypercholesterolemia and/or hypertriglyceridemia.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rovi Pharmaceuticals Laboratories

INDUSTRY

Sponsor Role collaborator

Equipe Enervit

UNKNOWN

Sponsor Role collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Alfredo Martinez

Main investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alfredo Martinez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Navarra

Santiago Navas-Carretero, PhD

Role: STUDY_CHAIR

University of Navarra

Itziar Abete, PhD

Role: STUDY_CHAIR

University of Navarra

M. Angeles Zulet, PhD

Role: STUDY_CHAIR

University of Navarra

Locations

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Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra

Pamplona, Navarre, Spain

Site Status

Countries

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Spain

References

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Navas-Carretero S, Abete I, Zulet MA, Martinez JA. Chronologically scheduled snacking with high-protein products within the habitual diet in type-2 diabetes patients leads to a fat mass loss: a longitudinal study. Nutr J. 2011 Jul 14;10:74. doi: 10.1186/1475-2891-10-74.

Reference Type RESULT
PMID: 21756320 (View on PubMed)

Related Links

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http://www.unav.es/master/nutricion-metabolismo/

European Master´s Degree in Feeding, Nutrition and Metabolism

Other Identifiers

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UNAV-ROVI-001-2010

Identifier Type: -

Identifier Source: org_study_id