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CompletedNCT01665339Updated Aug 15, 2012

Preload, Weight Management, Risk of Cardiovascular Disease

A Phase 3 interventional study of preload diet and control diet in Body Weight, sponsored by Isfahan University of Medical Sciences. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-15.

Sponsored by Isfahan University of Medical Sciences · Phase 3, Interventional, and Health services research

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Body Weight

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Keywords

  • preload
  • anthropometric measures
  • cardiovascular risk factors
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 132 are open to participants now.

This study's enrollment of 60 is close to the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

Isfahan University of Medical Sciences is the lead sponsor of 145 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI > 25,
  • older than 18 years

Exclusion criteria

Exclusion Criteria:

  • poor dietary compliance
05

Study design

Phase
Phase 3
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    preload

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

    Other: preload diet

  • Experimental
    control

    subjects in control group consumed salad and yogurt with meal.

    Other: control diet

Interventions

  • Otherpreload 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).

  • Othercontrol 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).

06

What researchers measure

Primary outcomes

  1. the amount of weight reduction in two dietary groups

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01665339
Lead sponsor
Isfahan University of Medical Sciences
Responsible party
Leila Azadbakht (Principal Investigator, Isfahan University of Medical Sciences) — Principal investigator
First posted
Aug 15, 2012
Start date
Sep 2011
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Aug 15, 2012

Study contacts

Leila Azadbakht, PhD
principal investigator · Isfahan University of Medical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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