Bread in Overweight/Obesity Treatment

October 18, 2010 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Evaluation of the Utility of an Hypocaloric Diet With or Without Bread in Overweight/Obesity Treatment

The purpose of this study is to determine the utility of an hypocaloric diet with or without bread in patients with overweight and obesity

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age > 18 years
  • sex female
  • signed informed consent
  • patient with overweight and obesity (IMC: > 25 < 39.9)

Exclusion Criteria:

  • Family and social environment that prevents compliance with treatment diet.
  • Having to perform any kind of diet special sickness associated: Celiac disease, chronic renal failure, etc.
  • patients with Diabetes Mellitus.
  • patients with Eating disorders.
  • patients with Dementia, Mental illness or impaired function cognitive.
  • consuming drugs or substances for losing weight (except in those cases in which suspension thereof 15 days of beginning the study).
  • Present disease which may interfere with weight loss: serious psychiatric disease, hypothyroidism not controlled.
  • Be pregnant or period of lactation.
  • Inability to comply with the physical activity plan agreed.
  • Want to quit smoking during the time that lasts for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group bread
group who received an hypocaloric balanced diet including bread
Other: hypocaloric diet balanced + nutrition education + ruled physical activity
Active Comparator: group without bread
group who received a hypocaloric balanced diet with exclusion of bread
Other: hypocaloric diet balanced + nutrition education + ruled physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in anthropometric parameters
Time Frame: after 16 weeks of start the diet
weight, height, BMI, fat mass, lean mass.
after 16 weeks of start the diet

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in biochemical parameters
Time Frame: after 16 weeks of start the diet
hematocrit, hemoglobin, lipid profile, ghrelin, leptin, adiponectin.
after 16 weeks of start the diet
Adherence
Time Frame: after 16 weeks of start the diet
Validated scale
after 16 weeks of start the diet
change in satiety and hunger Test
Time Frame: after 16 weeks of start the diet
visual analogue scale
after 16 weeks of start the diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Investigators

  • Principal Investigator: Carmen Gómez Candela, PhD, Jefe Unidad Nutrición Clínica y Dietética Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

October 18, 2010

First Posted (Estimate)

October 19, 2010

Study Record Updates

Last Update Posted (Estimate)

October 19, 2010

Last Update Submitted That Met QC Criteria

October 18, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP 753

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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