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Acceptability of LNS for Infants and Young Children in Guatemala

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University of California, Davis.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: June 22, 2010
Last Update Posted: June 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Academy for Educational Development
Information provided by:
University of California, Davis

This study aims to assess the acceptability of lipid-based nutrient supplements (LNS) for use as nutritional supplements for infants and young children in Guatemala.

The study will be conducted in three phases. Phase 1 will be a test-feeding to compare the acceptability of two different flavors of LNS (peanut and cinnamon) in infants and young children and their mothers or caregivers in terms of taste, smell and texture, as well as amount of the test-dose consumed. In Phase 2, children in the Phase 1 trial will receive a 2-week supply of one of the LNS products, which they will consume daily in their homes for 14 days under real-life conditions. Direct observation of supplement use and in-depth interviews with mothers, caregivers and health staff providing services in communities will be part of this phase too. In Phase 3, focus group discussions will be held with participants (mothers and caregivers) as well as with health staff providing services in communities to discuss different aspects of infant and child feeding and best ways for the LNS product to be used in the context of Guatemala.

We hypothesize that both flavors of LNS will be accepted by Guatemalan infants and young children children and their mothers or caregivers.

Condition Intervention
Malnutrition Dietary Supplement: Lipid-based supplement (LNS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Acceptability of Lipid-based Nutrient Supplements (LNS) for Infants and Young Children in Guatemala

Resource links provided by NLM:

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Acceptability of LNS [ Time Frame: Baseline ]
    Outcome will be assessed by amount of LNS consumed in the test trial, time of consumption, amount of LNS sachets consumed in the home-use trial and qualitative assessment of mothers and caregivers opinions.

Estimated Enrollment: 40
Study Start Date: May 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LNS supplement
Test-trial of two LNS flavors.
Dietary Supplement: Lipid-based supplement (LNS)
Infants and young children will receive 10 g of LNS for test trial during 3 consecutive days and thereafter, 20 g per day for 14 days.


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria Infants and Young Children:

  • Children 6-18 months of age.
  • Consuming solid foods for at least the past 30 days.
  • Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection).
  • No known allergy to peanuts or other food products (as reported on the screening questionnaire by the mother/primary caregiver).
  • Not severely malnourished [mid-upper arm circumference (MUAC) > 115 mm].
  • Maternal/caregiver willingness to feed the infant with LNS over a maximum 3 test days, and over the 2 week home-use period, and report on his/her consumption and reactions and practices for daily use. Willingness to participate in discussion groups.
  • Planning to remain in study area for at least the following three weeks.

Exclusion Criteria Infants and Young Children:

  • Children under 6 months of age.
  • All subjects with known peanut, soy or milk allergies.
  • In poor health or ill at the time of recruitment.
  • Severely malnourished children [mid-upper arm circumference (MUAC) < 115 mm].
  • Not willing to participate in study procedures.
  • Leaving the study area in the following three weeks.
  Contacts and Locations
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): NCT01148641

Contact: Kathryn G Dewey, PhD 530-752-0851 kgdewey@ucdavis.edu
Contact: Ana B Perez-Exposito, PhD 530-5747104 abperezexposito@ucdavis.edu

Fundacion de la Caficultura para el Dessarrollo Rural (FUNCAFE) Recruiting
Mazatenango, Suchitepequez, Guatemala, zona 1
Contact: Ana B Perez-Exposito, PhD    50-5747104    abperezexposito@ucdavis.edu   
Principal Investigator: Ana B Perez-Exposito, PhD         
Sponsors and Collaborators
University of California, Davis
Academy for Educational Development
Principal Investigator: Kathryn G Dewey, PhD University of California, Davis
  More Information

Responsible Party: Kathryn Dewey / Chair Program in International Nutrition, University of California, Davis
ClinicalTrials.gov Identifier: NCT01148641     History of Changes
Other Study ID Numbers: 201017829
First Submitted: June 18, 2010
First Posted: June 22, 2010
Last Update Posted: June 22, 2010
Last Verified: June 2010

Keywords provided by University of California, Davis:
Lipid-based supplements
Infant nutrition

Additional relevant MeSH terms:
Nutrition Disorders