Effects of Diet-induced Weight Loss in Obese Men

NCT01554865 | Completed Phase 4

• 1 other identifier: 2010075D
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction; Endothelial Dysfunction; Quality of Life; Inflammation

Keywords

obesity; men; sexual function; urinary tract symptoms; endothelial function; inflammation; quality of life

Outcome Measures

Primary Outcomes (1)

• erectile function

  increase in IIEF-5 score

  12 weeks

Secondary Outcomes (1)

• lower urinary tract symptoms

  12 weeks

Study Arms (2)

conventional diet counselling

ACTIVE COMPARATOR

counselling given by dietician on diet modification and caloric restriction

Behavioral: Conventional diet counseling

partial meal replacement diet

ACTIVE COMPARATOR

calorie-restricted diet using 1-2 meal replacements

Dietary Supplement: Optifast

Interventions

Optifast DIETARY_SUPPLEMENT

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

partial meal replacement diet

Conventional diet counseling BEHAVIORAL

conventional diet counselling

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, aged 30-65 years
• Body Mass Index (BMI) \>/= 27.5 kg/m2
• Waist circumference (WC) \>/= 90 cm

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Inflammation; Obesity; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Joan Khoo, MBBS,MRCP

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: December 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

SG (1)