Partial Meal Replacement and Inulin in Obese Women

This study has been completed.
Sponsor:
Collaborator:
Nucitec SA de CV
Information provided by (Responsible Party):
SANDRA GARCiA PADILLA, Cindetec
ClinicalTrials.gov Identifier:
NCT01505023
First received: January 4, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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 Intervention Phase
Obesity
Dietary Supplement: Partial meal replacement
Dietary Supplement: Partial meal replacement with inulin
Dietary Supplement: Inulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of a Partial Meal Replacement With Inulin on Obesity and Dyslipidemias in Women.

Resource links provided by NLM:


Further study details as provided by Cindetec:

Primary Outcome Measures:
  • Weight
  • Blood lipids

Secondary Outcome Measures:
  • Micronutrients intake

Enrollment: 179
Study Start Date: April 2006
Study Completion Date: February 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505023

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

No publications provided by Cindetec

Additional 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
Study First Received: January 4, 2012
Last Updated: January 4, 2012
Health Authority: Mexico: Ministry of Health

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

ClinicalTrials.gov processed this record on July 23, 2014