Clinical trial · Interventional
Effects of Diet-induced Weight Loss in Obese Men
The Effects of Diet-induced Weight Loss on Metabolic and Inflammatory Profile, Endothelial, Sexual and Urinary Function, and Quality of Life in Obese Men
NCT01554865CI-TRIAL-00018698completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endothelial Dysfunction | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional diet counseling | Behavioral | — | UNRESOLVED |
| Optifast | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- conventional diet counselling
- description
- counselling given by dietician on diet modification and caloric restriction
- interventionNames
- Behavioral: Conventional diet counseling
- type
- ACTIVE_COMPARATOR
- label
- partial meal replacement diet
- description
- calorie-restricted diet using 1-2 meal replacements
- interventionNames
- Dietary Supplement: Optifast
Primary outcomes (1)
- measure
- erectile function
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.