Endothelial Dysfunction, Inflammation, Quality of Life, Sexual Dysfunction
Conditions
Keywords
obesity, men, sexual function, urinary tract symptoms, endothelial function, inflammation, quality of life
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
Interventions
DIETARY_SUPPLEMENTOptifast
1-2 sachets of Optifast daily as part of diet modification (partial meal replacement diet)
BEHAVIORALConventional diet counseling
Sponsors
Changi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| erectile function | 12 weeks | increase in IIEF-5 score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lower urinary tract symptoms | 12 weeks | decrease in IPSS score |
Countries
Singapore
Outcome results
None listed