Effects of Diet-induced Weight Loss in Obese Men

NCT ID: NCT01554865

Last Updated: 2015-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-06-30

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

Conditions

Sexual Dysfunction; Endothelial Dysfunction; Quality of Life; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conventional diet counselling

counselling given by dietician on diet modification and caloric restriction

Group Type: ACTIVE_COMPARATOR

Conventional diet counseling

Intervention Type: BEHAVIORAL

partial meal replacement diet

calorie-restricted diet using 1-2 meal replacements

Group Type: ACTIVE_COMPARATOR

Optifast

Intervention Type: DIETARY_SUPPLEMENT

1-2 sachets of Optifast daily as part of diet modification (partial meal replacement diet)

Interventions

Optifast

1-2 sachets of Optifast daily as part of diet modification (partial meal replacement diet)

Intervention Type: DIETARY_SUPPLEMENT

Conventional diet counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Changi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan Khoo, MBBS,MRCP

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Locations

Changi General Hospital

Singapore, Singapore, Singapore

Countries

Singapore

Other Identifiers

2010075D

Identifier Type: -

Identifier Source: org_study_id