Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants (iLiNS-ACCEPT-M)

Tampere University

Status and phase

Completed

Phase 1

Conditions

Malnutrition

Treatments

Dietary Supplement: LNS-10gM

Dietary Supplement: LNS-20gNoM

Dietary Supplement: Nutributter

Dietary Supplement: LNS-20gM

Study type

Interventional

Funder types

Other

Identifiers

NCT00885144

iLiNS-ACCEPT-M

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

8 to 12 months old

Volunteers

Accepts Healthy Volunteers

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