Completed

Effect of Preload on Body Weight and Cardiovascular Risks

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What is being tested

preload diet

+ control diet

Other
Who is being recruted

Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

+ Body Weight

From 18 to 60 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Phase 3
Interventional
Study Start: September 2011
See protocol details

Summary

Principal SponsorIsfahan University of Medical Sciences
Last updated: August 15, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01665339
Principal SponsorIsfahan University of Medical Sciences
Last updated: August 15, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Signs and SymptomsPathological Conditions, Signs and SymptomsBody Weight

Criteria

2 inclusion criteria required to participate
BMI > 25
older than 18 years
1 exclusion criteria prevent from participating
poor dietary compliance

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Experimental
subjects in control group consumed salad and yogurt with meal.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers