Effects of Diet-induced Weight Loss in Obese Men

Phase 4

Completed

• Conditions: Inflammation; Sexual Dysfunction; Endothelial Dysfunction; Quality of Life
• Interventions: Behavioral: Conventional diet counseling; Dietary Supplement: Optifast

• Registration Number: NCT01554865
• Lead Sponsor: Changi General Hospital

Brief 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

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

• Male, aged 30-65 years
• Body Mass Index (BMI) >/= 27.5 kg/m2
• Waist circumference (WC) >/= 90 cm

Exclusion Criteria

• pituitary disease or cranial radiotherapy
• previous or current androgen replacement or deprivation therapy
• current treatment for sexual problems or LUTS
• glomerular filtration rate < 60 ml/min
• liver disease
• alcohol intake exceeding 500 g/week in the previous 12 months
• use of opiates, glucocorticoids, recreational drugs or phosphodiesterase inhibitors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional diet counselling	Conventional diet counseling	counselling given by dietician on diet modification and caloric restriction
partial meal replacement diet	Optifast	calorie-restricted diet using 1-2 meal replacements

Primary Outcome Measures

Name	Time	Method
erectile function	12 weeks	increase in IIEF-5 score

Secondary Outcome Measures

Name	Time	Method
lower urinary tract symptoms	12 weeks	decrease in IPSS score

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore