Preload, Weight Management, Risk of Car… | Clinical Trial

Key information

Conditions

Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

BMI > 25,
older than 18 years

Exclusion criteria

poor dietary compliance

Treatment and study plan

preload diet

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 diet

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).

Primary outcomes

the amount of weight reduction in two dietary groups

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Effect of Preload on Body Weight and Cardiovascular Risks

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Aug 15, 2012
Registry last updated: Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed