Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nutributter; LNS-20gM; LNS-20gNoM; LNS-10gM
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.; 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Stunting; Growth failure; Malnutrition; Lipid based nutrient supplement; LNS; Prevention; Malawi; Sub-Saharan Africa; Dietary supplementation