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Bread in Overweight/Obesity Treatment

F

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Status and phase

Completed
Phase 4

Conditions

Overweight
Obesity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01223989
HULP 753

Details and patient eligibility

About

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

Enrollment

122 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

122 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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