Effects of Diet-induced Weight Loss in Obese Men

July 27, 2015 updated by: Changi General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
erectile function
Time Frame: 12 weeks
increase in IIEF-5 score
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lower urinary tract symptoms
Time Frame: 12 weeks
decrease in IPSS score
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changi General Hospital

Investigators

  • Principal Investigator: Joan Khoo, MBBS,MRCP, Changi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

March 14, 2012

First Posted (ESTIMATE)

March 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010075D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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