Effects of Diet-induced Weight Loss in Obese Men

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554865
• Other study ID #: 2010075D
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2012
• Last updated: July 27, 2015
• Start date: December 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2015
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Inflammation
• Quality of Life
• Sexual Dysfunction

Intervention

Dietary Supplement:
• Optifast
1-2 sachets of Optifast daily as part of diet modification (partial meal replacement diet)

Behavioral:
• Conventional diet counseling

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	erectile function	increase in IIEF-5 score	12 weeks	No
Secondary	lower urinary tract symptoms	decrease in IPSS score	12 weeks	No