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Effects of Diet-induced Weight Loss in Obese Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Changi General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT01554865
First received: March 13, 2012
Last updated: March 14, 2012
Last verified: March 2012

March 13, 2012
March 14, 2012
December 2010
April 2012   (final data collection date for primary outcome measure)
erectile function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
increase in IIEF-5 score
Same as current
Complete list of historical versions of study NCT01554865 on ClinicalTrials.gov Archive Site
lower urinary tract symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
decrease in IPSS score
Same as current
Not Provided
Not Provided
 
Effects of Diet-induced Weight Loss in Obese Men
The Effects of Diet-induced Weight Loss on Metabolic and Inflammatory Profile, Endothelial, Sexual and Urinary Function, 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.

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sexual Dysfunction
  • Endothelial Dysfunction
  • Quality of Life
  • Inflammation
  • Dietary Supplement: Optifast
    1-2 sachets of Optifast daily as part of diet modification (partial meal replacement diet)
    Other Name: Optifast
  • Behavioral: Conventional diet counseling
  • Active Comparator: conventional diet counselling
    counselling given by dietician on diet modification and caloric restriction
    Intervention: Behavioral: Conventional diet counseling
  • Active Comparator: partial meal replacement diet
    calorie-restricted diet using 1-2 meal replacements
    Intervention: Dietary Supplement: Optifast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Male
30 Years to 65 Years
Yes
Contact: Joan Khoo +6581211542 joan_khoo@cgh.com.sg
Singapore
 
NCT01554865
2010075D
No
Changi General Hospital
Changi General Hospital
Not Provided
Principal Investigator: Joan Khoo, MBBS,MRCP Changi General Hospital
Changi General Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP