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Effects of Diet-induced Weight Loss in Obese Men

This study is currently recruiting participants.
Verified March 2012 by Changi General Hospital
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Sexual Dysfunction
Endothelial Dysfunction
Quality of Life
Inflammation
 Dietary Supplement: Optifast
Behavioral: Conventional diet counseling
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Diet-induced Weight Loss on Metabolic and Inflammatory Profile, Endothelial, Sexual and Urinary Function, and Quality of Life in Obese Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Changi General Hospital:

Primary Outcome Measures:
  • erectile function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    increase in IIEF-5 score


Secondary Outcome Measures:
  • lower urinary tract symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    decrease in IPSS score


Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional diet counselling
counselling given by dietician on diet modification and caloric restriction
 Behavioral: Conventional diet counseling
Active Comparator: partial meal replacement diet
calorie-restricted diet using 1-2 meal replacements
 Dietary Supplement: Optifast
1-2 sachets of Optifast daily as part of diet modification (partial meal replacement diet)
Other Name: Optifast

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

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554865

Contacts
Contact: Joan Khoo +6581211542 joan_khoo@cgh.com.sg

Locations
Singapore
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Joan Khoo     +6581211542     joan_khoo@cgh.com.sg    
Principal Investigator: Joan Khoo, MBBS, MRCP            
Sponsors and Collaborators
Changi General Hospital
Investigators
Principal Investigator: Joan Khoo, MBBS,MRCP Changi General Hospital
  More Information

No publications provided

Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT01554865     History of Changes
Other Study ID Numbers: 2010075D
Study First Received: March 13, 2012
Last Updated: March 14, 2012
Health Authority: Singapore: Ministry of Health

Keywords provided by Changi General Hospital:
obesity
men
sexual function
urinary tract symptoms
 endothelial function
inflammation
quality of life

Additional relevant MeSH terms:
Inflammation
Sexual Dysfunctions, Psychological
Weight Loss
Pathologic Processes
Sexual and Gender Disorders
 Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013