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Preload, Weight Management, Risk of Cardiovascular Disease

NCT ID: NCT01665339

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Body Weight

Keywords

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preload anthropometric measures cardiovascular risk factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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preload

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

Group Type EXPERIMENTAL

preload diet

Intervention Type OTHER

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

subjects in control group consumed salad and yogurt with meal.

Group Type EXPERIMENTAL

control diet

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI \> 25,
* older than 18 years

Exclusion Criteria

* poor dietary compliance
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Leila Azadbakht

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leila Azadbakht, PhD

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

Other Identifiers

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IUMS

Identifier Type: OTHER

Identifier Source: secondary_id

Effect of preload on weight

Identifier Type: -

Identifier Source: org_study_id