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Preload, Weight Management, Risk of Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT01665339
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Leila Azadbakht, Isfahan University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Body Weight Other: preload diet Other: control diet Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effect of Preload on Body Weight and Cardiovascular Risks
Study Start Date : September 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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).




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


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665339


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

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 )
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 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