Weight Loss in Pre-diabetic, Obese Women

Procter & Gamble (P&G)

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Dietary Supplement: Low calorie diet; Dietary Supplement: Olestra

Study type: Interventional

Funder types: Industry

Identifiers

NCT00686816

2008030

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 21 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Dietary Supplement: Low calorie diet

2

Experimental group

Treatment:

Dietary Supplement: Olestra