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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01665339
Other study ID # Effect of preload on weight
Secondary ID IUMS
Status Completed
Phase Phase 3
First received August 1, 2012
Last updated August 14, 2012
Start date September 2011
Est. completion date December 2011

Study information

Verified date August 2012
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- BMI > 25,

- older than 18 years

Exclusion Criteria:

- poor dietary compliance

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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).
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary the amount of weight reduction in two dietary groups 3 months Yes
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