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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
History of Changes
  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
Endpoint Classification: Safety Study
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

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

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

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI > 25,
  • older than 18 years

Exclusion Criteria:

  • poor dietary compliance
  Contacts and Locations
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

No publications provided

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
Study First Received: August 1, 2012
Last Updated: August 14, 2012
Health Authority: Iran: Ethics Committee

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

Additional relevant MeSH terms:
Body Weight
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013