Weight Loss in Pre-diabetic, Obese Women

This study has been completed.
Sponsor:
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00686816
First received: May 27, 2008
Last updated: October 15, 2009
Last verified: October 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight maintained [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 55 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Muhammad Rehman, MD, Procter & Gamble
ClinicalTrials.gov Identifier: NCT00686816     History of Changes
Other Study ID Numbers: 2008030
Study First Received: May 27, 2008
Last Updated: October 15, 2009
Health Authority: Russia: Government Scientific and Research Institute of Nutrition of Russian Academy of Medical Sciences

Keywords provided by Procter and Gamble:
pre-diabetic
obese

Additional relevant MeSH terms:
Prediabetic State
Weight Loss
Body Weight
Body Weight Changes
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014