NCT01665339

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

3 months

First QC Date

August 1, 2012

Last Update Submit

August 14, 2012

Conditions

Body Weight

Keywords

preloadanthropometric measurescardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

  • the amount of weight reduction in two dietary groups

    3 months

Study Arms (2)

preload

EXPERIMENTAL

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

Other: preload diet

control

EXPERIMENTAL

subjects in control group consumed salad and yogurt with meal.

Other: control diet

Interventions

preload dietOTHER

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).

preload
control dietOTHER

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 25,
  • older than 18 years

You may not qualify if:

  • poor dietary compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leila Azadbakht, PhD

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2012

First Posted

August 15, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 15, 2012

Record last verified: 2012-08