Weight Loss in Pre-diabetic, Obese Women

Phase 2

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Low calorie diet; Dietary Supplement: Olestra

• 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

Study Timeline

• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Study Start: 2008-07
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-15
• Last Update Posted: 2009-10-16

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

Arm && Interventions

Group	Intervention	Description
1	Low calorie diet	-
2	Olestra	-

Primary Outcome Measures

Name	Time	Method
weight loss	3 months

Secondary Outcome Measures

Name	Time	Method
Weight maintained	6 months

Trial Locations

Locations (1)

Vasily Isakov, MD; 🇷🇺 Moscow, Russian Federation