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Partial Meal Replacement and Inulin in Obese Women

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Partial meal replacement
Partial meal replacement with inulin
Inulin
Sponsored by
Cindetec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 50 Years (Adult)Female

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

Sites / Locations

  • Universidad Autónoma de Querétaro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

No Intervention

Arm Label

Partial meal replacement

Partial meal replacement with inulin

Inulin

No intervention

Arm Description

Outcomes

Primary Outcome Measures

Weight
Blood lipids

Secondary Outcome Measures

Micronutrients intake

Full Information

First Posted
January 4, 2012
Last Updated
January 4, 2012
Sponsor
Cindetec
Collaborators
Nucitec SA de CV
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1. Study Identification

Unique Protocol Identification Number
NCT01505023
Brief Title
Partial Meal Replacement and Inulin in Obese Women
Official Title
Evaluation of the Effectiveness of a Partial Meal Replacement With Inulin on Obesity and Dyslipidemias in Women.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cindetec
Collaborators
Nucitec SA de CV

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Partial meal replacement
Arm Type
Active Comparator
Arm Title
Partial meal replacement with inulin
Arm Type
Experimental
Arm Title
Inulin
Arm Type
Active Comparator
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Partial meal replacement
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Partial meal replacement with inulin
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin
Intervention Description
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).
Primary Outcome Measure Information:
Title
Weight
Title
Blood lipids
Secondary Outcome Measure Information:
Title
Micronutrients intake

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Eligibility Criteria
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
Facility Information:
Facility Name
Universidad Autónoma de Querétaro
City
Querétaro
ZIP/Postal Code
76230
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
22703579
Citation
Tovar AR, Caamano Mdel C, Garcia-Padilla S, Garcia 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.
Results Reference
derived

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Partial Meal Replacement and Inulin in Obese Women

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