Weight Loss in Pre-diabetic, Obese Women

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00686816

Enrollment

Registered

2008-05-30

Start date

2008-07-31

Completion date

2009-02-28

Last updated

2009-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

pre-diabetic, obese

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.

Interventions

DIETARY_SUPPLEMENTLow calorie diet

low calorie diet

DIETARY_SUPPLEMENTOlestra

low calorie Olestra diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
weight loss	3 months

Secondary

Measure	Time frame
Weight maintained	6 months

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026