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| Name | Class |
|---|---|
| Kamuzu University of Health Sciences | OTHER |
| University of California, Davis | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean amount (in grammes) of test food consumed | within 15 minutes of test feeding |
| Measure | Description | Time Frame |
|---|---|---|
| Mean time taken to consume the intervention dose | 15 minutes after test feeding | |
| Mean rating by the guardians (on a hedonic, 5 point scale) | 15 minutes after test feeding | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Ashorn, MD, PhD | Tampere University | Principal Investigator |
| Kenneth Maleta, MBBS, PhD | Kamuzu University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malawi, College of Medicine | Mangochi | Malawi |
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| Label | URL |
|---|---|
| College of Medicine homepage | View source |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D006130 | Growth Disorders |
| D005183 | Failure to Thrive |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Overall guardian feedback after a two week supplementation period (qualitative analysis of focus group discussions) |
| Once, when the children have completed a two-week supplementary feeding period |
| D012816 | Signs and Symptoms |