Bread in Overweight/Obesity Treatment

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223989
• Other study ID #: HULP 753
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2010
• Last updated: October 18, 2010
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: October 2010
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• hypocaloric diet balanced + nutrition education + ruled physical activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in anthropometric parameters	weight, height, BMI, fat mass, lean mass.	after 16 weeks of start the diet	No
Secondary	changes in biochemical parameters	hematocrit, hemoglobin, lipid profile, ghrelin, leptin, adiponectin.	after 16 weeks of start the diet	No
Secondary	Adherence	Validated scale	after 16 weeks of start the diet	No
Secondary	change in satiety and hunger Test	visual analogue scale	after 16 weeks of start the diet	No