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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

August 1, 2012
August 14, 2012
September 2011
December 2011   (final data collection date for primary outcome measure)
the amount of weight reduction in two dietary groups [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01665339 on ClinicalTrials.gov Archive Site
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Preload, Weight Management, Risk of Cardiovascular Disease
Effect of Preload on Body Weight and Cardiovascular Risks

Investigators presumed that preload consumers will have more weight reduction and lower risk of cardiovascular disease

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Body Weight
  • 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).
  • 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).
  • Experimental: preload
    subjects in preload group consumed salad, yogurt and water 15 minutes before the main meal.
    Intervention: Other: preload diet
  • Experimental: control
    subjects in control group consumed salad and yogurt with meal.
    Intervention: Other: control diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI > 25,
  • older than 18 years

Exclusion Criteria:

  • poor dietary compliance
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01665339
Effect of preload on weight, IUMS
No
Leila Azadbakht, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Not Provided
Principal Investigator: Leila Azadbakht, PhD Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP