Partial Meal Replacement and Inulin in Obese Women

NCT ID: NCT01505023

Last Updated: 2012-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-02-28

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Partial meal replacement

Group Type ACTIVE_COMPARATOR

Partial meal replacement

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Partial meal replacement with inulin

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

Inulin

Intervention Type DIETARY_SUPPLEMENT

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).

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type 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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nucitec SA de CV

UNKNOWN

Sponsor Role collaborator

Cindetec

OTHER

Sponsor Role lead

Responsible Party

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SANDRA GARCiA PADILLA

Clinical Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Autónoma de Querétaro

Querétaro City, Querétaro, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type DERIVED
PMID: 22703579 (View on PubMed)

Other Identifiers

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PEE-001-2004

Identifier Type: -

Identifier Source: org_study_id

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