Bread in Overweight/Obesity Treatment

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01223989

Enrollment

122

Registered

2010-10-19

Start date

2009-03-31

Completion date

2010-02-28

Last updated

2010-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

overweight, obesity, bread, hypocaloric diet

Brief 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

Interventions

OTHERhypocaloric diet balanced + nutrition education + ruled physical activity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026