Weight Loss in Pre-diabetic, Obese Women
Phase 2
Completed
- Conditions
- Obesity
- Registration Number
- NCT00686816
- Lead Sponsor
- Procter and Gamble
- Brief Summary
This is a six (6) month, single center, randomized, double-blind, parallel, controlled-feeding weight-loss study comparing two dietary groups (triglyceride and olestra) in pre-diabetic obese women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
- Premenopausal
- BMI 30-45 kg/meter squared
- waist circumference greater than 88 cm
- blood glucose level 5.8-6.9 mmol/l
Exclusion Criteria
- Pre-diabetic
- pregnant
- nursing
- food preferences not compatible with the study diet
- allergies or food sensitivities with any of the study diet
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method weight loss 3 months
- Secondary Outcome Measures
Name Time Method Weight maintained 6 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Olestra's weight loss effects in pre-diabetic obese women?
How does Olestra compare to standard-of-care weight loss interventions in pre-diabetic populations?
Are there specific biomarkers that predict response to Olestra in metabolic syndrome patients?
What adverse events are associated with Olestra use in long-term weight management strategies?
What non-digestible fat substitutes show synergistic effects with Olestra in obesity treatment?
Trial Locations
- Locations (1)
Vasily Isakov, MD
🇷🇺Moscow, Russian Federation
Vasily Isakov, MD🇷🇺Moscow, Russian Federation