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Preload, Weight Management, Risk of Cardiovascular Disease

Primary Purpose

Body Weight

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
preload diet
control diet
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Body Weight focused on measuring preload, anthropometric measures, cardiovascular risk factors

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI > 25,
  • older than 18 years

Exclusion Criteria:

  • poor dietary compliance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    preload

    control

    Arm Description

    subjects in preload group consumed salad, yogurt and water 15 minutes before the main meal.

    subjects in control group consumed salad and yogurt with meal.

    Outcomes

    Primary Outcome Measures

    the amount of weight reduction in two dietary groups

    Secondary Outcome Measures

    Full Information

    First Posted
    August 1, 2012
    Last Updated
    August 14, 2012
    Sponsor
    Isfahan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01665339
    Brief Title
    Preload, Weight Management, Risk of Cardiovascular Disease
    Official Title
    Effect of Preload on Body Weight and Cardiovascular Risks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Isfahan University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Body Weight
    Keywords
    preload, anthropometric measures, cardiovascular risk factors

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    preload
    Arm Type
    Experimental
    Arm Description
    subjects in preload group consumed salad, yogurt and water 15 minutes before the main meal.
    Arm Title
    control
    Arm Type
    Experimental
    Arm Description
    subjects in control group consumed salad and yogurt with meal.
    Intervention Type
    Other
    Intervention Name(s)
    preload diet
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    control diet
    Intervention Description
    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 Measure Information:
    Title
    the amount of weight reduction in two dietary groups
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI > 25, older than 18 years Exclusion Criteria: poor dietary compliance
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leila Azadbakht, PhD
    Organizational Affiliation
    Isfahan University of Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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