Partial Meal Replacement and Inulin in Obese Women

This study has been completed.

Sponsor:

Collaborator:

Nucitec SA de CV

Information provided by (Responsible Party):

SANDRA GARCiA PADILLA, Cindetec

ClinicalTrials.gov Identifier:

NCT01505023

First received: January 4, 2012

Last updated: NA

Last verified: January 2012

History: No changes posted

Tracking Information
First Received Date ^ICMJE	January 4, 2012
Last Updated Date	January 4, 2012
Start Date ^ICMJE	April 2006
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 4, 2012)	Weight Blood lipids
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: January 4, 2012)	Micronutrients intake
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Partial Meal Replacement and Inulin in Obese Women
Official Title ^ICMJE	Evaluation of the Effectiveness of a Partial Meal Replacement With Inulin on Obesity and Dyslipidemias in Women.
Brief 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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Obesity
Intervention ^ICMJE	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. Dietary Supplement: 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. Dietary Supplement: 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).
Study Arm (s)	Active Comparator: Partial meal replacement Intervention: Dietary Supplement: Partial meal replacement Experimental: Partial meal replacement with inulin Intervention: Dietary Supplement: Partial meal replacement with inulin Active Comparator: Inulin Intervention: Dietary Supplement: Inulin No Intervention: No intervention
Publications *	Tovar AR, Caamaño Mdel C, Garcia-Padilla S, García OP, Duarte MA, Rosado JL. The inclusion of a partial meal replacement with or without inulin to a calorie restricted diet contributes to reach recommended intakes of micronutrients and decrease plasma triglycerides: a randomized clinical trial in obese Mexican women. Nutr J. 2012 Jun 18;11:44. doi: 10.1186/1475-2891-11-44.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	179
Completion Date	February 2007
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Mexico

Administrative Information
NCT Number ^ICMJE	NCT01505023
Other Study ID Numbers ^ICMJE	PEE-001-2004
Has Data Monitoring Committee	No
Responsible Party	SANDRA GARCiA PADILLA, Cindetec
Study Sponsor ^ICMJE	Cindetec
Collaborators ^ICMJE	Nucitec SA de CV
Investigators ^ICMJE	Not Provided
Information Provided By	Cindetec
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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