Weight Loss in Pre-diabetic, Obese Women

Obesity Clinical Trial

Official title:

A Study Among Pre-diabetic, Obese Women to Evaluate the Weight Loss Effects of a Non-Digestible Fat Substitute

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686816
• Other study ID #: 2008030
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2008
• Last updated: October 15, 2009
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: October 2009
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Government Scientific and Research Institute of Nutrition of Russian Academy of Medical Sciences
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Prediabetic State

Intervention

Dietary Supplement:
• Low calorie diet
low calorie diet
• Olestra
low calorie Olestra diet

Locations

Country	Name	City	State
Russian Federation	Vasily Isakov, MD	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		3 months	No
Secondary	Weight maintained		6 months	No