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

This study has been completed.
Sponsor:
Collaborators:
Rovi Pharmaceuticals Laboratories
Equipe Enervit
Information provided by (Responsible Party):
Alfredo Martinez, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01264523
First received: December 20, 2010
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Type-2 Diabetes
Overweight
Other: Chronologically scheduled snacking with 40-30-30 products

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Short-term Effect of the Intake of Moderately High-protein, Low-glycemic Load Products on Anthropometrical, Glucose Metabolism and Lipid Metabolism Biomarkers, in Type-2 Diabetes Patients

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Total Body weight [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    Total body weight will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • Fat Mass [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    Fat Mass will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • Fat-free mass [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    Fat-free mass will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).


Secondary Outcome Measures:
  • Hip circumference [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    Hip circumference will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • Waist circumference [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    waist circumference will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • Basal glucose concentration [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    Basal glucose concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • Basal Insulin Concentration [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    Basal insulin concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • HOMA-IR index [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    HOMA-IR index will be calculated based on basal glucose and insulin levels, at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • Glucose postprandial response [ Time Frame: weeks 4 and 8 ] [ Designated as safety issue: No ]
    Glucose concentrations will be analysed during the postprandial period after the habitual and the intervention breakfast intake at the end of both periods (weeks 4 and 8). Blood extractions will be performed at 0, 30, 60 and 120 minutes after the ingestion of the breakfasts

  • Insulin postprandial response [ Time Frame: weeks 4 and 8 ] [ Designated as safety issue: No ]
    Insulin concentrations will be analysed during the postprandial period after the habitual and the intervention breakfast intake at the end of both periods (weeks 4 and 8). Blood extractions will be performed at 0, 30, 60 and 120 minutes after the ingestion of the breakfasts

  • Basal Total Cholesterol [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    Total cholesterol concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • HDL-Cholesterol [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    HDL-cholesterol concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • Triglycerides Levels [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    Triglycerides concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • LDL-cholesterol [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    LDL-cholesterol concentration will be calculated based on the FRiedewald Formula at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • C-Reactive Protein [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    C-Reactive Protein concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • Homocystein [ Time Frame: weeks 0, 4 and 8 ] [ Designated as safety issue: No ]
    Homocystein concentration will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

  • Dietary intake [ Time Frame: during first period (week 0-4) and second period (week 4-8) ] [ Designated as safety issue: No ]
    Dietary intake will be evaluated through 72h food records, which will be filled by the volunteers during 3 days in the habitual intake period (week 0-4) and during the intervention period (week 4-8)

  • Satiety assessment [ Time Frame: weeks 4 and 8 ] [ Designated as safety issue: No ]
    During the postprandial period after the ingestion of the habitual breakfast (week 4) and the 40-30-30 breakfast (week 8), volunteers will fill a total of four Visual Analogue Scale (VAS) questionnaires, at times 0, 30, 60 and 120 minutes.


Enrollment: 17
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: 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
    Other Name: Enervit, Zone diet
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264523

Locations
Spain
Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Rovi Pharmaceuticals Laboratories
Equipe Enervit
Investigators
Principal Investigator: Alfredo Martinez, PhD University of Navarra
Study Chair: Santiago Navas-Carretero, PhD University of Navarra
Study Chair: Itziar Abete, PhD University of Navarra
Study Chair: M. Angeles Zulet, PhD University of Navarra
  More Information

Additional Information:
Publications:
Responsible Party: Alfredo Martinez, Main investigator, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01264523     History of Changes
Other Study ID Numbers: UNAV-ROVI-001-2010
Study First Received: December 20, 2010
Last Updated: September 7, 2012
Health Authority: Spain: Comité de Ética de la Investigación de la Universidad de Navarra

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
chrononutrition
moderately high protein
glycemic index
type-2 diabetes
overweight
obesity
weight management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014