Partial Meal Replacement and Inulin in Obese Women

Obesity Clinical Trial

Official title:

Evaluation of the Effectiveness of a Partial Meal Replacement With Inulin on Obesity and Dyslipidemias in Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505023
• Other study ID #: PEE-001-2004
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2012
• Last updated: January 4, 2012
• Start date: April 2006
• Est. completion date: February 2007

Study information

• Verified date: January 2012
• Source: Cindetec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to test the efficacy of a partial meal replacement added with vitamins, minerals and inulin on weight reduction, blood lipids and micronutrients intake in obese Mexican women

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: February 2007
• Est. primary completion date: November 2006
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• BMI > 25 kg/m 2

Exclusion Criteria:

• Pregnant

• Lactating

• Diagnosed with diabetes

• Diagnosed with hypertension

• Fasting glucose =126 mg/dL

• Blood triglycerides =400mg/dL

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Partial meal replacement
The PMR was designed to contain sufficient amounts of all vitamins and minerals. Women were instructed to consume 2 servings per day at breakfast and dinner, each consisting of 33 g of powder dissolved in 250 ml of skim milk.
• Partial meal replacement with inulin
The PMR was designed to contain sufficient amounts of all vitamins and minerals plus inulin. Women were instructed to consume 2 servings per day at breakfast and dinner, each consisting of 33 g of powder dissolved in 250 ml of skim milk.
• Inulin
Women were asked to consume one 5g serving of inulin mixed with any drink at breakfast and same amount at dinner (10 g of inulin/d).

Locations

Country	Name	City	State
Mexico	Universidad Autónoma de Querétaro	Querétaro

Sponsors (2)

Lead Sponsor	Collaborator
Cindetec	Nucitec SA de CV

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight
Primary	Blood lipids
Secondary	Micronutrients intake