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Weight Loss in Pre-diabetic, Obese Women

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Low calorie diet
Olestra
Sponsored by
Procter and Gamble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring pre-diabetic, obese

Eligibility Criteria

21 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Vasily Isakov, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

weight loss

Secondary Outcome Measures

Weight maintained

Full Information

First Posted
May 27, 2008
Last Updated
October 15, 2009
Sponsor
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT00686816
Brief Title
Weight Loss in Pre-diabetic, Obese Women
Official Title
A Study Among Pre-diabetic, Obese Women to Evaluate the Weight Loss Effects of a Non-Digestible Fat Substitute
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Procter and Gamble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
pre-diabetic, obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Low calorie diet
Intervention Description
low calorie diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Olestra
Intervention Description
low calorie Olestra diet
Primary Outcome Measure Information:
Title
weight loss
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight maintained
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vasily Isakov, MD
Organizational Affiliation
Russian Institue of Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vasily Isakov, MD
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation

12. IPD Sharing Statement

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Weight Loss in Pre-diabetic, Obese Women

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