Preload, Weight Management, Risk of Cardiovascular Disease

Phase 3

Completed

• Conditions: Body Weight
• Interventions: Other: preload diet; Other: control diet

• Registration Number: NCT01665339
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-08
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-14
• Last Update Submitted: 2012-08-14
• Study First Posted: 2012-08-15
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• BMI > 25,
• older than 18 years

Exclusion Criteria

• poor dietary compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preload	preload diet	subjects in preload group consumed salad, yogurt and water 15 minutes before the main meal.
control	control diet	subjects in control group consumed salad and yogurt with meal.

Primary Outcome Measures

Name	Time	Method
the amount of weight reduction in two dietary groups	3 months