NCT01665339

Preload, Weight Management, Risk of Cardiovascular Disease

Effect of Preload on Body Weight and Cardiovascular Risks

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Isfahan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Body Weight

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2012-08-15
• Last updated: 2012-08-15