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Partial Meal Replacement and Inulin in Obese Women

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ClinicalTrials.gov Identifier: NCT01505023
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : January 6, 2012
Sponsor:
Collaborator:
Nucitec SA de CV
Information provided by (Responsible Party):
SANDRA GARCiA PADILLA, Cindetec

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

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Partial meal replacement Dietary Supplement: Partial meal replacement with inulin Dietary Supplement: Inulin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of a Partial Meal Replacement With Inulin on Obesity and Dyslipidemias in Women.
Study Start Date : April 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin
U.S. FDA Resources

Arm Intervention/treatment
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).
No Intervention: No intervention



Primary Outcome Measures :
  1. Weight
  2. Blood lipids

Secondary Outcome Measures :
  1. Micronutrients intake


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505023


Locations
Mexico
Universidad Autónoma de Querétaro
Querétaro, Mexico, 76230
Sponsors and Collaborators
Cindetec
Nucitec SA de CV

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SANDRA GARCiA PADILLA, Clinical Research Coordinator, Cindetec
ClinicalTrials.gov Identifier: NCT01505023     History of Changes
Other Study ID Numbers: PEE-001-2004
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms