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Acceptability of LNS for Infants and Young Children in Guatemala

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ClinicalTrials.gov Identifier: NCT01148641
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
FHI 360
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

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 was conducted in three phases. Phase 1 was 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 received a 2-week supply of one of the LNS products, which they consumed 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 (FGD) were 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 hypothesized that both flavors of LNS would be accepted by Guatemalan infants and young children children and their mothers or caregivers.


Condition or disease Intervention/treatment
Malnutrition Dietary Supplement: LNS

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Acceptability of Lipid-based Nutrient Supplements (LNS) for Infants and Young Children in Guatemala
Study Start Date : May 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
LNS-regular
Lipid-based nutrient supplement, regular (peanut) flavor
Dietary Supplement: LNS
Infants and young children will receive 10 g of LNS for test trial during 3 consecutive days (crossover design) and thereafter, 20 g per day for 14 days.
Other Name: Lipid-based nutrient supplement

LNS-cinnamon
Lipid-based nutrient supplement, cinnamon flavor
Dietary Supplement: LNS
Infants and young children will receive 10 g of LNS for test trial during 3 consecutive days (crossover design) and thereafter, 20 g per day for 14 days.
Other Name: Lipid-based nutrient supplement




Primary Outcome Measures :
  1. amount of LNS consumed [ Time Frame: 2 weeks ]
    Amount of LNS consumed in the test trial in grams

  2. time of consumption [ Time Frame: 2 weeks ]
    Avg how long it takes to eat the LNS mins

  3. amount of LNS sachets consumed in the home-use trial [ Time Frame: 2 weeks ]
    # of sachets consumed


Secondary Outcome Measures :
  1. qualitative assessment of mothers and caregivers opinions [ Time Frame: 2 weeks ]
    Focus group discussion (qualitative results) discuss different aspects of infant and child feeding and best ways for the LNS product to be used in the context of Guatemala.



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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
- Children 6-18 months of age.
Criteria

Inclusion Criteria:

  • 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:

  • 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.

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


Locations
Guatemala
Fundacion de la Caficultura para el Dessarrollo Rural (FUNCAFE)
Mazatenango, Suchitepequez, Guatemala, zona 1
Sponsors and Collaborators
University of California, Davis
FHI 360
Investigators
Principal Investigator: Kathryn G Dewey, PhD University of California, Davis

Additional Information:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01148641     History of Changes
Other Study ID Numbers: 201017829
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Keywords provided by University of California, Davis:
Lipid-based supplements
LNS
Acceptability
Infant nutrition
Guatemala
Malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders