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Preload, Weight Management, Risk of Cardiovascular Disease

Effect of Preload on Body Weight and Cardiovascular Risks

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01665339
Enrollment
60
Registered
2012-08-15
Start date
2011-09-30
Completion date
2011-12-31
Last updated
2012-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Weight

Keywords

preload, anthropometric measures, cardiovascular risk factors

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.

Interventions

OTHERpreload 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).

OTHERcontrol 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).

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI \> 25, * older than 18 years

Exclusion criteria

* poor dietary compliance

Design outcomes

Primary

MeasureTime frame
the amount of weight reduction in two dietary groups3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026