MalnutritionPhase 1iLiNS-ACCEPT-MNCT00885144
Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants
A Phase 1 study testing Nutributter, LNS-20gM and LNS-20gNoM in people with Malnutrition, run by Tampere University at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutributter, LNS-20gM and LNS-20gNoM
- How many people
- 19 participants
- Where
- 1 siteMalawi
- Study dates
- Apr 2009to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Acceptability of New Lipid Based Nutrient Supplement (LNS) Formulations for Prevention of Moderate Malnutrition
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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- Nutributter, LNS-20gM, LNS-20gNoM, LNS-10gM
- Keywords
- Stunting, Growth failure, Malnutrition, Lipid based nutrient supplement, LNS, Prevention, Malawi, Sub-Saharan Africa, Dietary supplementation
- Medical subject headings
- Malnutrition, Growth Disorders, Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutributterDietary 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-20gMDietary 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-20gNoMDietary 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-10gMDietary 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean amount (in grammes) of test food consumed
Measured: within 15 minutes of test feeding
Secondary outcomes (3)
Mean time taken to consume the intervention dose
Measured: 15 minutes after test feeding
Mean rating by the guardians (on a hedonic, 5 point scale)
Measured: 15 minutes after test feeding
Overall guardian feedback after a two week supplementation period (qualitative analysis of focus group discussions)
Measured: Once, when the children have completed a two-week supplementary feeding period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, University of California, Davis, Bill and Melinda Gates Foundation
- Investigators
- Per Ashorn, MD, PhD, Principal investigator, Tampere UniversityKenneth Maleta, MBBS, PhD, Principal investigator, Kamuzu University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885144
- Sponsor's protocol ID
- iLiNS-ACCEPT-M
- Acronym
- iLiNS-ACCEPT-M
- Status last verified
- Jun 2009
- First submitted
- 20 Apr 2009
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Acceptability of New Lipid Based Nutrient Supplement (LNS) Formulations for Prevention of Moderate Malnutrition
- ClinicalTrials.gov ID
- NCT00885144
- Acronym / sponsor ID
- iLiNS-ACCEPT-M / iLiNS-ACCEPT-M
- Conditions
- Malnutrition
- Keywords
- Stunting, Growth failure, Malnutrition, Lipid based nutrient supplement, LNS, Prevention, Malawi, Sub-Saharan Africa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, University of California, Davis, Bill and Melinda Gates Foundation
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
Who may qualify
- Ages
- 8 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutributterTest 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. | Dietary supplement | – |
| LNS-20gMTest 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. | Dietary supplement | – |
| LNS-20gNoMTest 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. | Dietary supplement | – |
| LNS-10gMTest 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. | Dietary supplement | – |
Primary outcome
Mean amount (in grammes) of test food consumed
Time frame: within 15 minutes of test feeding
3 secondary outcomes
Mean time taken to consume the intervention dose
Time frame: 15 minutes after test feeding
Mean rating by the guardians (on a hedonic, 5 point scale)
Time frame: 15 minutes after test feeding
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2009.
- College of Medicine homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Ashorn, MD, PhD principal investigator
Tampere University
Kenneth Maleta, MBBS, PhD principal investigator
Kamuzu University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nutributter, LNS-20gM and LNS-20gNoM in people with Malnutrition, run by Tampere University at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean amount (in grammes) of test food consumed (time frame: within 15 minutes of test feeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2009.