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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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ClinicalTrials.gov Identifier: NCT02559479
Recruitment Status : Unknown
Verified December 2016 by Fernando Civeira, Instituto Aragones de Ciencias de la Salud.
Recruitment status was:  Recruiting
First Posted : September 24, 2015
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
Fernando Civeira, Instituto Aragones de Ciencias de la Salud

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in glucose. [ Time Frame: After 3 and 6 months of intervention. ]
  2. Change in glycated hemoglobin. [ Time Frame: After 3 and 6 months of intervention. ]
  3. Change in insulin resistance (HOMA index). [ Time Frame: After 3 and 6 months of intervention. ]

Secondary Outcome Measures :
  1. Change in body weight. [ Time Frame: After 3 and 6 months of intervention. ]
  2. Change in body composition. [ Time Frame: After 3 and 6 months of intervention. ]
  3. Change in waist circumference. [ Time Frame: After 3 and 6 months of intervention. ]
  4. Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, non HDL cholesterol, triglycerides and apolipoproteins). [ Time Frame: After 3 and 6 months of intervention. ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559479


Contacts
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Contact: Fernando Civeira, MD, PhD +34 976765500 ext 2884 civeira@unizar.es
Contact: Rocio Mateo-Gallego, RD, PhD rmateo.iacs@aragon.es

Locations
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Spain
Fernando Civeira Recruiting
Zaragoza, Spain, 50009
Contact: Rocio Mateo-Gallego, RD, PhD    +34 976765500 ext 2895    rmateo.iacs@aragon.es   
Contact: Victoria Marco-Benedí, RD    +34 976765500 ext 2895    vito2911@hotmail.com   
Sponsors and Collaborators
Instituto Aragones de Ciencias de la Salud
Investigators
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Principal Investigator: Fernando Civeira, MD, PhD Unidad Clínica y de Investigación en Lípidos y Arteriosclerosis; Hospital U. Miguel Servet; IIS Aragón
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: September 24, 2015    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight