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Weight Loss in Pre-diabetic, Obese Women

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ClinicalTrials.gov Identifier: NCT00686816
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : October 16, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Low calorie diet Dietary Supplement: Olestra Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1 Dietary Supplement: Low calorie diet
low calorie diet
Experimental: 2 Dietary Supplement: Olestra
low calorie Olestra diet



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

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


Information from the National Library of Medicine

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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

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

Responsible Party: Muhammad Rehman, MD, Procter & Gamble
ClinicalTrials.gov Identifier: NCT00686816     History of Changes
Other Study ID Numbers: 2008030
First Posted: May 30, 2008    Key Record Dates
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
Body Weight Changes
Body Weight
Prediabetic State
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