Partial Meal Replacement and Inulin in Obese Women

January 4, 2012 updated by: SANDRA GARCiA PADILLA, Cindetec

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Querétaro, Mexico, 76230
        • Universidad Autónoma de Querétaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention
Active Comparator: Partial meal replacement
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.
Experimental: Partial meal replacement with inulin
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.
Active Comparator: Inulin
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Weight
Blood lipids

Secondary Outcome Measures

Outcome Measure
Micronutrients intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cindetec

Collaborators

Nucitec SA de CV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 4, 2012

First Posted (Estimate)

January 6, 2012

Study Record Updates

Last Update Posted (Estimate)

January 6, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEE-001-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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