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Completed

NCT Number: NCT00885144

Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants

The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. The investigators' study group has developed modified versions of such supplements that theoretically will supplement infants diets better and with lower cost. As a preparation for larger efficacy trials, the investigators now aim to test the acceptability of these supplements among Malawian infants and their guardians. The trial hypothesis is that the infants will consume on average at least 50% of an offered dose that consists of LNS mixed with maize porridge.

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Key information

Conditions

Malnutrition Failure to Thrive Growth Disorders Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Malawi, College of Medicine

Mangochi, Malawi

About this study

In the first phase, 18 infants meeting set criteria are randomised into receiving three test meals with novel LNS preparations over a three-day period. The meals will consists of the following, each given on one day and in a random order: 1) 7.5 g of LNS-10gM mixed in 30 g maize-soy porridge, 2) 15 g of LNS-20gM mixed in 30 g maize-soy porridge, 3) 15 g of LNS-20gNoM mixed in 30 g maize-soy porridge. As a run in procedure, each participant will undergo a test feeding session with one of the the test foods on the day before the actual test-feeding period. As a positive control, each participant will undergo test feeding session with standard Nutributter (NB) on the day after the actual test-feeding period.

In the second phase a set of 48 infants are randomised into 3 groups receiving the following food supplements for a period of 2 weeks: 1) 10 g/day of milk-containing, very concentrated LNS (LNS-10gM), 2) 20 g/day of milk-containing, concentrated LNS (LNS-20gM), 3) 20 g/day of milk-free, concentrated LNS (LNS-20 g NoM)

Outcomes measures in the first phase will be assessed through safety reports and quantities of test food consumed by the child and a hedonic scale of acceptability by the mothers of the children. The second phase will be assessed with qualitative outcomes, from data obtained from focus group discussions with the guardians of the infants consuming the test foods.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent from at least one guardian
  • Age 7.50 months to 11.49 months
  • Currently breastfeeding
  • Consuming complementary feeds at least 30 days prior to enrollment
  • Availability during the period of the study

Exclusion criteria

  • Weight for length Z score (WFH) ≤ -2.0 using WHO growth reference standards or the -presence of oedema
  • Severe systemic illness warranting hospital referral
  • History of allergy towards peanut
  • History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
  • Congenital malformation such as cleft palate which may interfere with food intake
  • Concurrent participation in any other clinical trial

Treatment and study plan

Nutributter

Dietary Supplement

Test dose of "standard" supplementary lipid based nutrient supplement (LNS). 15 grams of Nutributter will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.

LNS-20gM

Dietary Supplement

Test dose of modified LNS-20gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.

LNS-20gNoM

Dietary Supplement

Test dose of modified LNS-20gNoM (milk free) supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gNoM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.

LNS-10gM

Dietary Supplement

Test dose of modified LNS-10gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-10gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.

Primary outcomes

  1. Mean amount (in grammes) of test food consumed

    Time frame: within 15 minutes of test feeding

Secondary outcomes

  1. Mean time taken to consume the intervention dose

    Time frame: 15 minutes after test feeding

  2. Mean rating by the guardians (on a hedonic, 5 point scale)

    Time frame: 15 minutes after test feeding

  3. Overall guardian feedback after a two week supplementation period (qualitative analysis of focus group discussions)

    Time frame: Once, when the children have completed a two-week supplementary feeding period

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Kamuzu University of Health Sciences
  • University of California, Davis

Registry information

Official study title

Differential Acceptability of New Lipid Based Nutrient Supplement (LNS) Formulations for Prevention of Moderate Malnutrition

Acronym: iLiNS-ACCEPT-M

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 21, 2009
Registry last updated
Jun 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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