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A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes

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Last updated:1st Sep 2015

The objective of the study is to assess the effect of low-calorie diets with normal (18%) vs. high (35%) protein (mainly coming from animal source) composition on body weight and carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. A dietary intervention is carried out during 6 months in 100 subjects who are individually randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35% protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates. Around 80% of total protein in diet comes from animal source (of whom around 40% from lean red meat). Subjects are provided with weekly menus and different recipes to use them as part of the diet. Monitoring visits with the nutritionist will be performed every 15 days. At the beginning of the study, after 3 and 6 months, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1 and B, iron, transferring, ferritin, uric acid, glucose, HbA1c, insulin, adiponectin and resistin). Urine samples are also collected to assess microalbuminuria and ureic nitrogen.

Study Type: Interventional

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Open Label

Primary Purpose: Treatment

Official Title: A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes

Estimated Enrollment: 100

Study Start Date: September 2015

Estimated Study Completion Date: September 2016

Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Arms:

Active Comparator: 18%-Protein diet
Energy-restricted diet wit the following composition: 18% protein, 30% fat and 52% carbohydrates

Active Comparator: 35%-Protein diet
Energy-restricted diet wit the following composition: 35% protein, 30% fat and 35% carbohydrates

Category Value
Study start date 2015-09-01

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