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

Overweight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264523
• Other study ID #: UNAV-ROVI-001-2010
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: September 7, 2012
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2012
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité de Ética de la Investigación de la Universidad de Navarra
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Overweight
• Type-2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Spain	Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra	Pamplona	Navarra

Sponsors (3)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Equipe Enervit, Rovi Pharmaceuticals Laboratories

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Navas-Carretero S, Abete I, Zulet MA, Martínez 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: 10.1186/1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No

External Links

•   Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
•   European Master´s Degree in Feeding, Nutrition and Metabolism