Effects of Diet-induced Weight Loss in Obese Men

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Sexual Dysfunction, Endothelial Dysfunction, Quality of Life, Inflammation

Intervention / Treatment
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* Dietary Supplement: Optifast
* Behavioral: Conventional diet counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional diet counselling<br>counselling given by dietician on diet modification and caloric restriction | Behavioral: Conventional diet counseling<br> <br> |
| Active Comparator: partial meal replacement diet<br>calorie-restricted diet using 1-2 meal replacements | Dietary Supplement: Optifast<br>* 1-2 sachets of Optifast daily as part of diet modification (partial meal replacement diet)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erectile function | increase in IIEF-5 score | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower urinary tract symptoms | decrease in IPSS score | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, men, sexual function, urinary tract symptoms, endothelial function, inflammation, quality of life