Weight Loss in Pre-diabetic, Obese Women | NCT00686816

Studies
Weight Loss in Pre-diabetic, Obese Women

NCT00686816

Sponsor

Procter and Gamble

Status

Completed

Last Update Posted

Oct 16, 2009Estimated

Enrollment

80Actual

Phase

Phase 2

Conditions

Obesity

Interventions

Low calorie diet
Olestra

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

May 27, 2008

First Submission Date that Met QC Criteria

May 29, 2008

First Posted Date

May 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2009

Last Update Posted Date

Oct 16, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Dietary Supplement: Low calorie diet
2	Experimental		Dietary Supplement: Olestra

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low calorie diet	Dietary Supplement	low calorie diet	1
Olestra

Measure	Description	Time Frame
weight loss		3 months

Measure	Description	Time Frame
Weight maintained		6 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vasily Isakov, MD	Russian Institue of Nutrition	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vasily Isakov, MD		Moscow		109240	Russia

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D018149	Glucose Intolerance

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D031204	Caloric Restriction
C013692	sucrose polyester

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D002149	Energy Intake

Browse Leaves

Not provided

Browse Branches

Not provided