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

• Sponsor: Instituto Aragones de Ciencias de la Salud (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02559479
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss; Obesity; Diabetes; Diet, Reducing; Carbohydrates; Protein	Behavioral: Weight loss interventional study with a low-calorie 18%-protein diet; Behavioral: Weight loss interventional study with a low-calorie 35%-protein diet	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2015
• Anticipated Primary Completion Date: Jun 1, 2017
• Anticipated Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 18%-Protein diet Energy-restricted diet wit the following composition: 18% protein, 30% fat and 52% carbohydrates	Behavioral: Weight loss interventional study with a low-calorie 18%-protein diet
Active Comparator: 35%-Protein diet Energy-restricted diet wit the following composition: 35% protein, 30% fat and 35% carbohydrates	Behavioral: Weight loss interventional study with a low-calorie 35%-protein diet

Outcome Measures

Primary Outcome Measures

1. Change in glucose. [After 3 and 6 months of intervention.]

2. Change in glycated hemoglobin. [After 3 and 6 months of intervention.]

3. Change in insulin resistance (HOMA index). [After 3 and 6 months of intervention.]

Secondary Outcome Measures

1. Change in body weight. [After 3 and 6 months of intervention.]

2. Change in body composition. [After 3 and 6 months of intervention.]

3. Change in waist circumference. [After 3 and 6 months of intervention.]

4. Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, non HDL cholesterol, triglycerides and apolipoproteins). [After 3 and 6 months of intervention.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age: 18-70 years old.

• Body mass index between 27.5 - 40.

• Steady weight (± 4 kg) in the last 2 months.

• Glycated hemoglobin between 6 - 7%.

Exclusion Criteria:

• Anti-diabetic drugs (oral or subcutaneous) in the last 2 months.

• Lipid-lowering drugs in the last 2 months.

• Gouty arthritis in the last 2 years or uric acid > 735 mg/dl.

• Presence of uncontrolled endocrinological pathology (including hypothyroidism).

• Hepatic chronic disease (glomerular filtration rate < 45 ml/min).

• Renal, inflammatory or tumoral diseases.

• Drugs which could interfere in glucose or lipid metabolism such as androgens, corticosteroids (except for those with topic administration) and estrogen replacement therapy.

• Intake of functional foods with plant sterols in the past 6 weeks.

• High alcohol intake (> 30 g per day).

• Any serious disease which involves less than 1 year life expectancy or, in investigators judgment, limit the follow-up of an homogeneous diet throughout the study.

• Pregnancy or intention of pregnancy during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fernando Civeira	Zaragoza		Spain	50009

Sponsors and Collaborators

• Instituto Aragones de Ciencias de la Salud

Investigators

• Principal Investigator: Fernando Civeira, MD, PhD, Unidad Clínica y de Investigación en Lípidos y Arteriosclerosis; Hospital U. Miguel Servet; IIS Aragón

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fernando Civeira, Professor, Instituto Aragones de Ciencias de la Salud
• ClinicalTrials.gov Identifier: NCT02559479
• Other Study ID Numbers: CEICA;PI/15/0183
• First Posted: Sep 24, 2015
• Last Update Posted: Dec 2, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Diabetes Mellitus; Prediabetic State; Weight Loss

Study Results

No Results Posted as of Dec 2, 2016