## Protocol Section
### Identification Module
**NCT ID:** NCT02559479

**Brief Title:** 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

#### Organization Study ID Info
**ID:** CEICA;PI/15/0183
#### Organization
**Class:** OTHER_GOV
**Full Name:** Instituto Aragones de Ciencias de la Salud
### Status Module
#### Completion Date
**Date:** 2017-06

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2016-12-02

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-12-01

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-09

**Status Verified Date:** 2016-12

#### Study First Post Date
**Date:** 2015-09-24
**Type:** ESTIMATED
**Study First Submit Date:** 2015-09-22
**Study First Submit QC Date:** 2015-09-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Instituto Aragones de Ciencias de la Salud

#### Responsible Party

**Investigator Affiliation:** Instituto Aragones de Ciencias de la Salud

**Investigator Full Name:** Fernando Civeira

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Weight Loss

- Obesity

- Diabetes

- Diet, Reducing

- Carbohydrates

- Protein

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Energy-restricted diet wit the following composition: 18% protein, 30% fat and 52% carbohydrates

**Intervention Names:**

- Behavioral: Weight loss interventional study with a low-calorie 18%-protein diet

**Label:** 18%-Protein diet

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Energy-restricted diet wit the following composition: 35% protein, 30% fat and 35% carbohydrates

**Intervention Names:**

- Behavioral: Weight loss interventional study with a low-calorie 35%-protein diet

**Label:** 35%-Protein diet

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 18%-Protein diet

**Name:** Weight loss interventional study with a low-calorie 18%-protein diet

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- 35%-Protein diet

**Name:** Weight loss interventional study with a low-calorie 35%-protein diet

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in glucose.

**Time Frame:** After 3 and 6 months of intervention.

**Measure:** Change in glycated hemoglobin.

**Time Frame:** After 3 and 6 months of intervention.

**Measure:** Change in insulin resistance (HOMA index).

**Time Frame:** After 3 and 6 months of intervention.

#### Secondary Outcomes

**Measure:** Change in body weight.

**Time Frame:** After 3 and 6 months of intervention.

**Measure:** Change in body composition.

**Time Frame:** After 3 and 6 months of intervention.

**Measure:** Change in waist circumference.

**Time Frame:** After 3 and 6 months of intervention.

**Measure:** 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.

### Eligibility Module

**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.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** civeira@unizar.es

**Name:** Fernando Civeira, MD, PhD

**Phone:** +34 976765500

**Phone Ext:** 2884

**Role:** CONTACT

**Contact 2:**

**Email:** rmateo.iacs@aragon.es

**Name:** Rocio Mateo-Gallego, RD, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Zaragoza

**Contacts:**

***Contact 1:***

- **Email:** rmateo.iacs@aragon.es

- **Name:** Rocio Mateo-Gallego, RD, PhD

- **Phone:** +34 976765500

- **Phone Ext:** 2895

- **Role:** CONTACT

***Contact 2:***

- **Email:** vito2911@hotmail.com

- **Name:** Victoria Marco-Benedí, RD

- **Phone:** +34 976765500

- **Phone Ext:** 2895

- **Role:** CONTACT

**Country:** Spain

**Facility:** Fernando Civeira

**Status:** RECRUITING

**Zip:** 50009

#### Overall Officials

**Official 1:**

**Affiliation:** Unidad Clínica y de Investigación en Lípidos y Arteriosclerosis; Hospital U. Miguel Servet; IIS Aragón

**Name:** Fernando Civeira, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** YES

### References Module

#### 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.

**PMID:** 31255349

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001836

- Term: Body Weight Changes

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M18102

- Name: Weight Loss

- Relevance: HIGH

- As Found: Weight Loss

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M14117

- Name: Prediabetic State

- Relevance: HIGH

- As Found: Prediabetes

- ID: M20295

- Name: Glucose Intolerance

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5115

- Name: Body Weight Changes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000011236

- Term: Prediabetic State

- ID: D000015431

- Term: Weight Loss

### Misc Info Module

- Version Holder: 2024-05-24
