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

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Type-2 Diabetes
• Intervention / Treatment: Other: Chronologically scheduled snacking with 40-30-30 products

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Body weight	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).	weeks 0, 4 and 8
Fat Mass	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).	weeks 0, 4 and 8
Fat-free mass	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).	weeks 0, 4 and 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip circumference	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).	weeks 0, 4 and 8
Waist circumference	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).	weeks 0, 4 and 8
Basal glucose concentration	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).	weeks 0, 4 and 8
Basal Insulin Concentration	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).	weeks 0, 4 and 8
HOMA-IR index	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).	weeks 0, 4 and 8
Glucose postprandial response	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	weeks 4 and 8
Insulin postprandial response	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	weeks 4 and 8
Basal Total Cholesterol	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).	weeks 0, 4 and 8
HDL-Cholesterol	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).	weeks 0, 4 and 8
Triglycerides Levels	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).	weeks 0, 4 and 8
LDL-cholesterol	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).	weeks 0, 4 and 8
C-Reactive Protein	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).	weeks 0, 4 and 8
Homocystein	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).	weeks 0, 4 and 8
Dietary intake	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)	during first period (week 0-4) and second period (week 4-8)
Satiety assessment	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.	weeks 4 and 8

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: Rovi Pharmaceuticals Laboratories; Equipe Enervit
• Investigators: Principal Investigator: Alfredo Martinez, PhD, University of Navarra; Study Chair: Itziar Abete, PhD, University of Navarra

Publications and helpful links

General Publications

• 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.

Helpful Links

• European Master´s Degree in Feeding, Nutrition and Metabolism

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: December 20, 2010
• First Posted (ESTIMATE): December 21, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 10, 2012
• Last Update Submitted That Met QC Criteria: September 7, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: obesity; overweight; glycemic index; weight management; chrononutrition; moderately high protein; type-2 diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
• Other Study ID Numbers: UNAV-ROVI-001-2010