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OpenTrials
Completed

NCT Number: NCT00686816

Weight Loss in Pre-diabetic, Obese Women

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.

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Key information

Conditions

Obesity Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Vasily Isakov, MD

Moscow, 109240, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low calorie diet

Dietary Supplement

low calorie diet

Olestra

Dietary Supplement

low calorie Olestra diet

Primary outcomes

  1. weight loss

    Time frame: 3 months

Secondary outcomes

  1. Weight maintained

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 30, 2008
Registry last updated
Oct 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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