Nutritional Intervention With Moderately High-protein, Low-glycemic Load Products in Type-2 Diabetes Patients
- Conditions
- Type-2 DiabetesOverweight
- Registration Number
- NCT01264523
- Lead Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- Clinically diagnosed of type-2 Diabetes
- Under dietary treatment or with Metformin
- Body Mass Index (BMI) Between 22 and 35 kg/m2
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Total Body weight weeks 0, 4 and 8 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 weeks 0, 4 and 8 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 weeks 0, 4 and 8 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
Name Time Method Waist circumference weeks 0, 4 and 8 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).
Hip circumference weeks 0, 4 and 8 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).
Basal glucose concentration weeks 0, 4 and 8 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 weeks 0, 4 and 8 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 weeks 0, 4 and 8 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 weeks 4 and 8 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 weeks 4 and 8 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 weeks 0, 4 and 8 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 weeks 0, 4 and 8 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 weeks 0, 4 and 8 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 weeks 0, 4 and 8 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 weeks 0, 4 and 8 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 weeks 0, 4 and 8 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 during first period (week 0-4) and second period (week 4-8) 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 weeks 4 and 8 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.
Trial Locations
- Locations (1)
Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
🇪🇸Pamplona, Navarra, Spain