A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedDecember 2, 2016
December 1, 2016
1.8 years
September 22, 2015
December 1, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
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.
Study Arms (2)
18%-Protein diet
ACTIVE COMPARATOREnergy-restricted diet wit the following composition: 18% protein, 30% fat and 52% carbohydrates
35%-Protein diet
ACTIVE COMPARATOREnergy-restricted diet wit the following composition: 35% protein, 30% fat and 35% carbohydrates
Interventions
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fernando Civeira
Zaragoza, Zaragoza, 50009, Spain
Related Publications (1)
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.
PMID: 31255349DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando Civeira, MD, PhD
Unidad Clínica y de Investigación en Lípidos y Arteriosclerosis; Hospital U. Miguel Servet; IIS Aragón
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 22, 2015
First Posted
September 24, 2015
Study Start
September 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
December 2, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will share