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

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 Overview

• Status: Unknown
• Conditions: Obesity; Diabetes; Weight Loss; Protein; Diet, Reducing; Carbohydrates
• Intervention / Treatment: Behavioral: Weight loss interventional study with a low-calorie 18%-protein diet; Behavioral: Weight loss interventional study with a low-calorie 35%-protein diet

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernando Civeira, MD, PhD; Phone Number: 2884 +34 976765500; Email: civeira@unizar.es
• Study Contact Backup: Name: Rocio Mateo-Gallego, RD, PhD; Email: rmateo.iacs@aragon.es

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Recruiting
    • Fernando Civeira
    • Contact: Rocio Mateo-Gallego, RD, PhD; Phone Number: 2895 +34 976765500; Email: rmateo.iacs@aragon.es
    • Contact: Victoria Marco-Benedí, RD; Phone Number: 2895 +34 976765500; Email: vito2911@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in glucose.	After 3 and 6 months of intervention.
Change in glycated hemoglobin.	After 3 and 6 months of intervention.
Change in insulin resistance (HOMA index).	After 3 and 6 months of intervention.

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in body weight.	After 3 and 6 months of intervention.
Change in body composition.	After 3 and 6 months of intervention.
Change in waist circumference.	After 3 and 6 months of intervention.
Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, non HDL cholesterol, triglycerides and apolipoproteins).	After 3 and 6 months of intervention.

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Marco-Benedi V, Perez-Calahorra S, Bea AM, Lamiquiz-Moneo I, Baila-Rueda L, Cenarro A, Civeira F, Mateo-Gallego R. High-protein energy-restricted diets induce greater improvement in glucose homeostasis but not in adipokines comparing to standard-protein diets in early-onset diabetic adults with overweight or obesity. Clin Nutr. 2020 May;39(5):1354-1363. doi: 10.1016/j.clnu.2019.06.005. Epub 2019 Jun 15.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: September 22, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (Estimate): September 24, 2015

Study Record Updates

• Last Update Posted (Estimate): December 2, 2016
• Last Update Submitted That Met QC Criteria: December 1, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Body Weight Changes; Diabetes Mellitus; Weight Loss; Prediabetic State
• Other Study ID Numbers: CEICA;PI/15/0183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No