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Preload, Weight Management, Risk of Cardiovascular Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leila Azadbakht, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01665339
First received: August 1, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose
Investigators presumed that preload consumers will have more weight reduction and lower risk of cardiovascular disease

Condition Intervention Phase
Body Weight Other: preload diet Other: control diet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effect of Preload on Body Weight and Cardiovascular Risks

Resource links provided by NLM:


Further study details as provided by Leila Azadbakht, Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • the amount of weight reduction in two dietary groups [ Time Frame: 3 months ]

Enrollment: 60
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: preload
subjects in preload group consumed salad, yogurt and water 15 minutes before the main meal.
Other: preload diet
All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).
Experimental: control
subjects in control group consumed salad and yogurt with meal.
Other: control diet
All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).

Detailed Description:
To our knowledge, all previous studies evaluated the energy intake in a dietary meal after consuming a low-energy-dense preload while none assessed the sustainability of lower amount of energy intake and body weight changes in a long-term. On the other hand, the sustainability of lower energy intake in a long term might be affected by higher dietary diversity score due to considering preload in diets. Notably, increased diet variety is associated with higher overall dietary energy intake and weight gain.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI > 25,
  • older than 18 years

Exclusion Criteria:

  • poor dietary compliance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665339

Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Leila Azadbakht, PhD Isfahan University of Medical Sciences
  More Information

Responsible Party: Leila Azadbakht, Principal Investigator, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01665339     History of Changes
Other Study ID Numbers: Effect of preload on weight
IUMS ( Other Identifier: Isfahan University of Medical Sciences )
Study First Received: August 1, 2012
Last Updated: August 14, 2012

Keywords provided by Leila Azadbakht, Isfahan University of Medical Sciences:
preload
anthropometric measures
cardiovascular risk factors

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 26, 2017