Clinical trial NCT01264523: Nutritional Intervention With Moderately High-protein, Low-glycemic Load Products in Type-2 Diabetes Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type-2 Diabetes
Overweight
Keywords: chrononutrition
moderately high protein
glycemic index
type-2 diabetes
overweight
obesity
weight management
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Rovi Pharmaceuticals Laboratories
name: Equipe Enervit
First posted: 2010-12-21
Enrollment: 17
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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: 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 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.

Primary outcomes:
measure: Total Body weight
timeFrame: weeks 0, 4 and 8
measure: Fat Mass
timeFrame: weeks 0, 4 and 8
measure: Fat-free mass
timeFrame: weeks 0, 4 and 8
Secondary outcomes:
measure: Hip circumference
timeFrame: weeks 0, 4 and 8
measure: Waist circumference
timeFrame: weeks 0, 4 and 8
measure: Basal glucose concentration
timeFrame: weeks 0, 4 and 8
measure: Basal Insulin Concentration
timeFrame: weeks 0, 4 and 8
measure: HOMA-IR index
timeFrame: weeks 0, 4 and 8
measure: Glucose postprandial response
timeFrame: weeks 4 and 8
measure: Insulin postprandial response
timeFrame: weeks 4 and 8
measure: Basal Total Cholesterol
timeFrame: weeks 0, 4 and 8
measure: HDL-Cholesterol
timeFrame: weeks 0, 4 and 8
measure: Triglycerides Levels
timeFrame: weeks 0, 4 and 8
measure: LDL-cholesterol
timeFrame: weeks 0, 4 and 8
measure: C-Reactive Protein
timeFrame: weeks 0, 4 and 8
measure: Homocystein
timeFrame: weeks 0, 4 and 8
measure: Dietary intake
timeFrame: during first period (week 0-4) and second period (week 4-8)
measure: Satiety assessment
timeFrame: weeks 4 and 8
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
state: Navarra
Study officials:
affiliation: University of Navarra
name: Alfredo Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Navarra
name: Santiago Navas-Carretero, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Itziar Abete, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: M. Angeles Zulet, PhD
role: STUDY_CHAIR
References:
citation: 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.