Effects of Diet-induced Weight Loss in Obese Men

Changi General Hospital

Status and phase: Completed; Phase 4

Conditions: Inflammation; Endothelial Dysfunction; Quality of Life; Sexual Dysfunction

Treatments: Behavioral: Conventional diet counseling; Dietary Supplement: Optifast

Study type: Interventional

Funder types: Other

Identifiers

NCT01554865

2010075D

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

conventional diet counselling

Active Comparator group

Description:

counselling given by dietician on diet modification and caloric restriction

Treatment:

Behavioral: Conventional diet counseling

partial meal replacement diet

Active Comparator group

Description:

calorie-restricted diet using 1-2 meal replacements

Treatment:

Dietary Supplement: Optifast