Clinical trial NCT02559479: A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Obesity
Diabetes
Diet, Reducing
Carbohydrates
Protein
Lead sponsor: Instituto Aragones de Ciencias de la Salud
Sponsor class: OTHER_GOV
First posted: 2015-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in glucose.
timeFrame: After 3 and 6 months of intervention.
measure: Change in glycated hemoglobin.
timeFrame: After 3 and 6 months of intervention.
measure: Change in insulin resistance (HOMA index).
timeFrame: After 3 and 6 months of intervention.
Secondary outcomes:
measure: Change in body weight.
timeFrame: After 3 and 6 months of intervention.
measure: Change in body composition.
timeFrame: After 3 and 6 months of intervention.
measure: Change in waist circumference.
timeFrame: After 3 and 6 months of intervention.
measure: Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, non HDL cholesterol, triglycerides and apolipoproteins).
timeFrame: After 3 and 6 months of intervention.
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Fernando Civeira
Study officials:
affiliation: Unidad Clínica y de Investigación en Lípidos y Arteriosclerosis; Hospital U. Miguel Servet; IIS Aragón
name: Fernando Civeira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.