Back to resultsEffects of Diet-induced Weight Loss in Obese Men
Primary Purpose
Sexual Dysfunction, Endothelial Dysfunction, Quality of Life
Status
Completed
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Optifast
Conventional diet counseling
Sponsored by
About this trial
This is an interventional treatment trial for Sexual Dysfunction focused on measuring obesity, men, sexual function, urinary tract symptoms, endothelial function, inflammation, quality of life
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
Sites / Locations
- Changi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
conventional diet counselling
partial meal replacement diet
Arm Description
counselling given by dietician on diet modification and caloric restriction
calorie-restricted diet using 1-2 meal replacements
Outcomes
Primary Outcome Measures
erectile function
increase in IIEF-5 score
Secondary Outcome Measures
lower urinary tract symptoms
decrease in IPSS score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01554865
Brief Title
Effects of Diet-induced Weight Loss in Obese Men
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changi General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Endothelial Dysfunction, Quality of Life, Inflammation
Keywords
obesity, men, sexual function, urinary tract symptoms, endothelial function, inflammation, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional diet counselling
Arm Type
Active Comparator
Arm Description
counselling given by dietician on diet modification and caloric restriction
Arm Title
partial meal replacement diet
Arm Type
Active Comparator
Arm Description
calorie-restricted diet using 1-2 meal replacements
Intervention Type
Dietary Supplement
Intervention Name(s)
Optifast
Intervention Description
1-2 sachets of Optifast daily as part of diet modification (partial meal replacement diet)
Intervention Type
Behavioral
Intervention Name(s)
Conventional diet counseling
Primary Outcome Measure Information:
Title
erectile function
Description
increase in IIEF-5 score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
lower urinary tract symptoms
Description
decrease in IPSS score
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Khoo, MBBS,MRCP
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
Effects of Diet-induced Weight Loss in Obese Men
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