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

Tracking Information

First Received Date ^ICMJE

March 13, 2012

Last Updated Date

March 14, 2012

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

erectile function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

increase in IIEF-5 score

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01554865 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

lower urinary tract symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

decrease in IPSS score

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Diet-induced Weight Loss in Obese Men

Official Title ^ICMJE

The Effects of Diet-induced Weight Loss on Metabolic and Inflammatory Profile, Endothelial, Sexual and Urinary Function, and Quality of Life in Obese Men

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Sexual Dysfunction
Endothelial Dysfunction
Quality of Life
Inflammation

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2012

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

30 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Joan Khoo

+6581211542

joan_khoo@cgh.com.sg

Location Countries ^ICMJE

Singapore

Administrative Information

NCT Number ^ICMJE

NCT01554865

Other Study ID Numbers ^ICMJE

2010075D

Has Data Monitoring Committee

Responsible Party

Changi General Hospital

Study Sponsor ^ICMJE

Changi General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Joan Khoo, MBBS,MRCP

Changi General Hospital

Information Provided By

Changi General Hospital

Verification Date

March 2012

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

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