Skip to main content
OpenTrials
Completed

NCT Number: NCT01223989

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hypocaloric diet balanced + nutrition education + ruled physical activity

Other

Primary outcomes

  1. changes in anthropometric parameters

    Time frame: after 16 weeks of start the diet

    weight, height, BMI, fat mass, lean mass.

Secondary outcomes

  1. changes in biochemical parameters

    Time frame: after 16 weeks of start the diet

    hematocrit, hemoglobin, lipid profile, ghrelin, leptin, adiponectin.

  2. Adherence

    Time frame: after 16 weeks of start the diet

    Validated scale

  3. change in satiety and hunger Test

    Time frame: after 16 weeks of start the diet

    visual analogue scale

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2010
Registry last updated
Oct 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.