NCT01554865

Effects of Diet-induced Weight Loss in Obese Men

The Effects of Diet-induced Weight Loss on Metabolic and Inflammatory Profile, Endothelial, Sexual and Urinary Function, and Quality of Life in Obese Men

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Changi General Hospital · Academic / Other
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study aims to compare the efficacy of a partial meal replacement diet with a conventional diet, for inducing weight loss and improving metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men.

Detailed description

This study aims to compare the efficacy of a partial meal replacement diet with a conventional diet, for inducing weight loss, and improving metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men. Men aged 30-65 years, with body mass index (BMI) ≥ 27.5 kg/m2, will be recruited from the community in Singapore. The study will be conducted at Changi General Hospital by trained medical investigators, dieticians and sports trainers. At baseline and 12 weeks, fasting glucose and lipids, insulin, testosterone, sex-hormone binding globulin, serum C-reactive protein and interleukin-6 are measured, endothelial function is measured by the non-invasive EndoPAT method, and validated questionnaires administered to assess changes in erectile function, sexual desire, LUTS and quality of life

Conditions

• Sexual Dysfunction
• Endothelial Dysfunction
• Quality of Life
• Inflammation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Optifast	1-2 sachets of Optifast daily as part of diet modification (partial meal replacement diet)
BEHAVIORAL	Conventional diet counseling

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-03-15
• Last updated: 2015-07-29

Locations

1 site across 1 country: Singapore