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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional diet counselling | Active Comparator | counselling given by dietician on diet modification and caloric restriction |
|
| partial meal replacement diet | Active Comparator | calorie-restricted diet using 1-2 meal replacements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optifast | Dietary Supplement | 1-2 sachets of Optifast daily as part of diet modification (partial meal replacement diet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| erectile function | increase in IIEF-5 score | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| lower urinary tract symptoms | decrease in IPSS score | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Khoo, MBBS,MRCP | Changi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Singapore | Singapore | 529889 | Singapore |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D007249 | Inflammation |
| D009765 | Obesity |
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Conventional diet counseling | Behavioral |
|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |