Weight Loss in Pre-diabetic, Obese Women

NCT ID: NCT00686816

Last Updated: 2009-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Low calorie diet

Intervention Type DIETARY_SUPPLEMENT

low calorie diet

2

Group Type EXPERIMENTAL

Olestra

Intervention Type DIETARY_SUPPLEMENT

low calorie Olestra diet

Interventions

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Low calorie diet

low calorie diet

Intervention Type DIETARY_SUPPLEMENT

Olestra

low calorie Olestra diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role lead

Responsible Party

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Procter & Gamble

Principal Investigators

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Vasily Isakov, MD

Role: PRINCIPAL_INVESTIGATOR

Russian Institue of Nutrition

Locations

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Vasily Isakov, MD

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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2008030

Identifier Type: -

Identifier Source: org_study_id

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