Partial Meal Replacement and Inulin in Obese Women
Evaluation of the Effectiveness of a Partial Meal Replacement With Inulin on Obesity and Dyslipidemias in Women.
1 other identifier
interventional
179
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
Started Apr 2006
Shorter than P25 for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 4, 2012
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedJanuary 6, 2012
January 1, 2012
7 months
January 4, 2012
January 4, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Weight
Blood lipids
Secondary Outcomes (1)
Micronutrients intake
Study Arms (4)
Partial meal replacement
ACTIVE COMPARATORPartial meal replacement with inulin
EXPERIMENTALInulin
ACTIVE COMPARATORNo intervention
NO INTERVENTIONInterventions
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.
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.
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).
Eligibility Criteria
You may qualify if:
- BMI \> 25 kg/m 2
You may not qualify if:
- Pregnant
- Lactating
- Diagnosed with diabetes
- Diagnosed with hypertension
- Fasting glucose ≥126 mg/dL
- Blood triglycerides ≥400mg/dL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cindeteclead
- Nucitec SA de CVcollaborator
Study Sites (1)
Universidad Autónoma de Querétaro
Querétaro City, Querétaro, 76230, Mexico
Related Publications (1)
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.
PMID: 22703579DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research Coordinator
Study Record Dates
First Submitted
January 4, 2012
First Posted
January 6, 2012
Study Start
April 1, 2006
Primary Completion
November 1, 2006
Study Completion
February 1, 2007
Last Updated
January 6, 2012
Record last verified: 2012-01