NCT00686816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

7 months

First QC Date

May 27, 2008

Last Update Submit

October 15, 2009

Conditions

Obesity

Keywords

pre-diabeticobese

Outcome Measures

Primary Outcomes (1)

  • weight loss

    3 months

Secondary Outcomes (1)

  • Weight maintained

    6 months

Study Arms (2)

1

PLACEBO COMPARATOR
Dietary Supplement: Low calorie diet

2

EXPERIMENTAL
Dietary Supplement: Olestra

Interventions

Low calorie dietDIETARY_SUPPLEMENT

low calorie diet

1
OlestraDIETARY_SUPPLEMENT

low calorie Olestra diet

2

Eligibility Criteria

Age21 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal
  • BMI 30-45 kg/meter squared
  • waist circumference greater than 88 cm
  • blood glucose level 5.8-6.9 mmol/l

You may not qualify if:

  • Pre-diabetic
  • pregnant
  • nursing
  • food preferences not compatible with the study diet
  • allergies or food sensitivities with any of the study diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vasily Isakov, MD

Moscow, 109240, Russia

Location

MeSH Terms

Conditions

ObesityGlucose Intolerance

Interventions

Caloric Restrictionsucrose polyester

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Vasily Isakov, MD

    Russian Institue of Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

July 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

RU(1)