We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Weight Loss in Pre-diabetic, Obese Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00686816
First Posted: May 30, 2008
Last Update Posted: October 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Procter and Gamble
  Purpose
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.

Condition Intervention Phase
Obesity Dietary Supplement: Low calorie diet Dietary Supplement: Olestra Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study Among Pre-diabetic, Obese Women to Evaluate the Weight Loss Effects of a Non-Digestible Fat Substitute

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • weight loss [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Weight maintained [ Time Frame: 6 months ]

Enrollment: 80
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Dietary Supplement: Low calorie diet
low calorie diet
Experimental: 2 Dietary Supplement: Olestra
low calorie Olestra diet

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686816


Locations
Russian Federation
Vasily Isakov, MD
Moscow, Russian Federation, 109240
Sponsors and Collaborators
Procter and Gamble
Investigators
Principal Investigator: Vasily Isakov, MD Russian Institue of Nutrition
  More Information

Responsible Party: Muhammad Rehman, MD, Procter & Gamble
ClinicalTrials.gov Identifier: NCT00686816     History of Changes
Other Study ID Numbers: 2008030
First Submitted: May 27, 2008
First Posted: May 30, 2008
Last Update Posted: October 16, 2009
Last Verified: October 2009

Keywords provided by Procter and Gamble:
pre-diabetic
obese

Additional relevant MeSH terms:
Weight Loss
Prediabetic State
Body Weight Changes
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sucrose polyester
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents