Stunting of GrowthNCT07804667
Pilot Study of a Modified Therapeutic Food Compared With a Standard Nutrient Supplement in Young Children in Rural Guatemala
A study testing Modified Therapeutic Food Formulation and Nutri Listo SQ-LNS in people with Stunting of Growth and Chronic Malnutrition, run by Wuqu' Kawoq, Maya Health Alliance at 1 site in Guatemala.
Trial summary
The goal of this clinical trial is to learn whether a modified food supplement is acceptable and well tolerated by children aged 12 to 24 months with mild-to-moderate stunting in rural Guatemala. Read more about this study
- Who is it for?
- Ages 12 to 24 months
- Conditions the study is for
- Stunting of Growth, Chronic Malnutrition
- What is being tested?
- Modified Therapeutic Food Formulation and Nutri Listo SQ-LNS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGuatemala
- Study dates
- 15 Sep 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 12 to 24 months at enrollment
- Mild-to-moderate stunting, defined as height-for-age Z-score (HAZ) less than -1 and greater than -3
- Primary caregiver willing and able to provide informed consent
- Caregiver has access to a phone or WhatsApp, or has a trusted proxy such as a family member or neighbor who can assist with phone calls or WhatsApp communication
Who cannot join
- Moderate or severe acute malnutrition, defined as weight-for-height Z-score (WHZ) less than -2
- Antibiotic use within the preceding 14 days
- Known food allergy or intolerance to study ingredients, including peanut, dairy, or egg
- History of persistent diarrhea, defined as watery stools lasting more than 7 consecutive days within the past month
- Caregiver report of frequent or severe abdominal distension or pain occurring shortly after consumption of fiber-rich foods
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guatemala1 site
Centro Comunitario de Salud Chuti Estancia
San Andrés Semetabaj, Departamento de Sololá
Wendy Rodriguez, MD, +502 3029 1150, wendyrodriguez@wuqukawoq.org
Wendy Rodriguez, MD
About this study
Official title: A Pilot Study to Evaluate the Acceptability, Tolerability, and Short-Term Biological Signals of a Modified Therapeutic Food Compared to a Standard Lipid-Based Nutrient Supplement in Children Aged 12-24 Months in Rural Guatemala
The goal of this clinical trial is to learn whether a modified food supplement is acceptable and well tolerated by children aged 12 to 24 months with mild-to-moderate stunting in rural Guatemala. The study will also explore whether the food is associated with short-term changes in stool markers related to gut inflammation and microbial activity.
The main questions are:
Read more
- Will children accept and regularly eat the modified food supplement?
- What stomach or bowel symptoms, if any, occur while children eat the supplement?
- Do stool markers related to gut health change over the short study period?
Researchers will compare the modified food supplement with Nutri Listo, a small-quantity lipid-based nutrient supplement already used in Guatemala. Children will be assigned by chance to one of the two groups.
Participants will:
- Complete a brief taste and acceptability test
- Eat one 30-gram sachet of the assigned food each day for 21 days
- Have their caregiver receive brief phone or WhatsApp check-ins during the study
- Provide a stool sample near the beginning and end of the study
This is a small pilot study. It is designed to assess feasibility, acceptability, tolerability, and early biological signals rather than to determine whether the modified food improves growth or other clinical outcomes.
Read the detailed description
This randomized, open-label pilot study will compare a modified food supplement with Nutri Listo, a small-quantity lipid-based nutrient supplement currently used in Guatemala. Approximately 36 children aged 12 to 24 months with mild-to-moderate stunting will be enrolled and assigned to one of two study groups.
The modified formulation combines commonly consumed food ingredients and nutrients, including peanut, green banana, chickpea, whey protein, vegetable oil, vitamins, and minerals. The comparison group will receive Nutri Listo. Both groups will receive one 30-gram sachet per day for 21 days.
The study is primarily designed to evaluate whether the modified formulation can be feasibly delivered and is acceptable and well tolerated under home-based conditions. Caregivers will be contacted regularly during the intervention to assess product consumption and gastrointestinal symptoms. Stool samples will be collected near baseline and at the end of the intervention to explore short-term changes in markers of intestinal inflammation, microbial fermentation, and gut microbiome composition.
This pilot is intended to generate feasibility and preliminary biological data that can inform the design of larger studies. It is not powered to determine effects on child growth or other clinical outcomes.
- Conditions
- Stunting of Growth, Chronic Malnutrition
- Being tested
- Modified Therapeutic Food Formulation, Nutri Listo SQ-LNS
- Keywords
- Childhood stunting, Therapeutic food, Small-quantity lipid-based nutrient supplement, Gut microbiome, Environmental enteric dysfunction, Guatemala
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Therapeutic Food FormulationDietary supplement
A nutrient-dense, food-based supplement packaged in single-use 30-gram sachets. The formulation includes green banana flour, chickpea flour, roasted peanut paste, high-oleic oil, whey protein concentrate, micronutrients, and other food ingredients. Participants receive 30 grams daily for 21 days.
Nutri Listo SQ-LNSDietary supplement
Also called Nutri Listo
A commercially available small-quantity lipid-based nutrient supplement used in Guatemala for young children. For this study, Nutri Listo is provided in 30-gram sachets with the daily micronutrient amount adjusted for the study. Participants receive 30 grams daily for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Modified Therapeutic Food Formulation | Experimental | Participants will receive one 30-gram sachet of the modified therapeutic food formulation daily for 21 days. During the first 3 days, caregivers will divide the daily sachet into two approximately 15-gram servings. From Day 4 onward, the full daily amount may be given at one time or divided based on caregiver preference. Receives: Dietary Supplement: Modified Therapeutic Food Formulation |
| Nutri Listo SQ-LNS | Active comparator | Participants will receive one 30-gram sachet of Nutri Listo small-quantity lipid-based nutrient supplement daily for 21 days, with micronutrients adjusted for the study daily total. During the first 3 days, caregivers will divide the daily sachet into two approximately 15-gram servings. From Day 4 onward, the full daily amount may be given at one time or divided based on caregiver preference. Receives: Dietary Supplement: Nutri Listo SQ-LNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and palatability of the study product
Acceptability and palatability will be assessed using structured study questionnaires. During the initial taste test, staff will record the amount of modified therapeutic food consumed, observed feeding behavior, and whether the caregiver believes the child would eat the product every day. At endline, caregivers will rate overall acceptance of the assigned study product on a 4-point scale: refused most of the time (1), accepted with difficulty (2), accepted well (3), or liked it very much (4). Unabbreviated title: Therapeutic Acceptability Score. Range: 1 (worst) to 4 (best).
Measured: Initial taste test (Day 0) and endline assessment (Day 22)
Adherence to daily study product consumption
Adherence will be assessed during scheduled WhatsApp or telephone monitoring contacts using caregiver reports of whether the child consumed all, some, or none of the assigned product. At endline, staff will count remaining sachets and collect used sachets or wrappers to estimate product consumption during the 21-day home-feeding period.
Measured: Days 1 through 21, with endline assessment on Day 22
Frequency and severity of gastrointestinal symptoms
During scheduled monitoring contacts, caregivers will report gastrointestinal symptoms occurring since the previous contact, including stomach pain, diarrhea or loose stools, vomiting, and bloating or gas. Symptom severity will be recorded as none, mild, or severe, and the specific symptom type will be documented when symptoms are reported.
Measured: Days 1 through 21
Secondary outcomes (7)
Change in fecal calprotectin concentration
Fecal calprotectin will be measured using standard clinical assays in baseline and endline stool samples as a marker of intestinal inflammation. The outcome is the change in fecal calprotectin concentration from baseline to endline. Exploratory analyses will also compare the baseline-to-endline change between the modified therapeutic food and Nutri Listo arms.
Measured: Baseline to endline (Day 22)
Change in fecal short-chain fatty acid concentrations
Fecal short-chain fatty acids, including acetate, propionate, and butyrate, will be measured using established analytical methods in baseline and endline stool samples. The outcome is the change in short-chain fatty acid concentrations from baseline to endline. Exploratory analyses will also compare changes between the modified therapeutic food and Nutri Listo arms.
Measured: Baseline to endline (Day 22)
Directional change in gut microbiome composition
Gut microbiome composition will be assessed using 16S ribosomal RNA gene sequencing of baseline and endline stool samples. Analyses will characterize overall bacterial community structure and the relative abundance of major bacterial taxa and assess directional changes from baseline to endline. Exploratory analyses will also compare changes between study arms.
Measured: Baseline to endline (Day 22)
Fecal pH
Fecal pH will be assessed in stool samples collected at baseline and endline.
Measured: Baseline and endline (Day 22)
Fecal sIgA
Fecal sIgA will be assessed in baseline and endline stool samples as an exploratory marker related to gut integrity. This analysis is planned if resources are available.
Measured: Baseline and endline (Day 22)
Fecal alpha-1-antitrypsin (A1AT)
Fecal alpha-1-antitrypsin (A1AT) will be assessed in baseline and endline stool samples using a standard ELISA as an exploratory marker related to gut integrity. This analysis is planned if resources are available.
Measured: Baseline and endline (Day 22)
Fecal Reg1B
Fecal Reg1B will be assessed in baseline and endline stool samples using a standard ELISA as an exploratory marker related to gut integrity. This analysis is planned if resources are available.
Measured: Baseline and endline (Day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stunting of GrowthStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to one of two parallel study arms: a modified food supplement or the Nutri Listo small-quantity lipid-based nutrient supplement comparator. Each participant receives the assigned product for 21 days.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuqu' Kawoq, Maya Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperación Listo Maní+, S.A., Arizona State University
- Responsible party
- Sponsor
- Investigators
- Lee Gaeddert, PhD, Principal investigator, Wuqu' Kawoq, Maya Health AllianceWendy Rodriguez, MD, Principal investigator, Wuqu' Kawoq, Maya Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804667
- Sponsor's protocol ID
- WK 2026 003
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie results reported in study publications will be made available to qualified researchers upon reasonable request, subject to applicable ethics, consent, privacy, and data-use requirements. De-identified microbiome sequencing data and limited non-identifying metadata will be deposited in an appropriate public repository when required by the journal or repository standards. Direct participant identifiers will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Acceptability, Tolerability, and Short-Term Biological Signals of a Modified Therapeutic Food Compared to a Standard Lipid-Based Nutrient Supplement in Children Aged 12-24 Months in Rural Guatemala
- ClinicalTrials.gov ID
- NCT07804667
- Acronym / sponsor ID
- WK 2026 003
- Conditions
- Stunting of Growth, Chronic Malnutrition
- Keywords
- Childhood stunting, Therapeutic food, Small-quantity lipid-based nutrient supplement, Gut microbiome, Environmental enteric dysfunction, Guatemala
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Wuqu' Kawoq, Maya Health AllianceUniversity, hospital or other
- Collaborators
- Cooperación Listo Maní+, S.A., Arizona State University
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 4 Sep 2026 (actual)
- 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 goal of this clinical trial is to learn whether a modified food supplement is acceptable and well tolerated by children aged 12 to 24 months with mild-to-moderate stunting in rural Guatemala. The study will also explore whether the food is associated with short-term changes in stool markers related to gut inflammation and microbial activity.
The main questions are:
- Will children accept and regularly eat the modified food supplement?
- What stomach or bowel symptoms, if any, occur while children eat the supplement?
- Do stool markers related to gut health change over the short study period?
Researchers will compare the modified food supplement with Nutri Listo, a small-quantity lipid-based nutrient supplement already used in Guatemala. Children will be assigned by chance to one of the two groups.
Participants will:
- Complete a brief taste and acceptability test
- Eat one 30-gram sachet of the assigned food each day for 21 days
- Have their caregiver receive brief phone or WhatsApp check-ins during the study
- Provide a stool sample near the beginning and end of the study
This is a small pilot study. It is designed to assess feasibility, acceptability, tolerability, and early biological signals rather than to determine whether the modified food improves growth or other clinical outcomes.
Detailed description
This randomized, open-label pilot study will compare a modified food supplement with Nutri Listo, a small-quantity lipid-based nutrient supplement currently used in Guatemala. Approximately 36 children aged 12 to 24 months with mild-to-moderate stunting will be enrolled and assigned to one of two study groups.
The modified formulation combines commonly consumed food ingredients and nutrients, including peanut, green banana, chickpea, whey protein, vegetable oil, vitamins, and minerals. The comparison group will receive Nutri Listo. Both groups will receive one 30-gram sachet per day for 21 days.
The study is primarily designed to evaluate whether the modified formulation can be feasibly delivered and is acceptable and well tolerated under home-based conditions. Caregivers will be contacted regularly during the intervention to assess product consumption and gastrointestinal symptoms. Stool samples will be collected near baseline and at the end of the intervention to explore short-term changes in markers of intestinal inflammation, microbial fermentation, and gut microbiome composition.
This pilot is intended to generate feasibility and preliminary biological data that can inform the design of larger studies. It is not powered to determine effects on child growth or other clinical outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two parallel study arms: a modified food supplement or the Nutri Listo small-quantity lipid-based nutrient supplement comparator. Each participant receives the assigned product for 21 days.
| Arm | Type | Receives |
|---|---|---|
| Modified Therapeutic Food Formulation | Experimental | Dietary Supplement: Modified Therapeutic Food FormulationParticipants will receive one 30-gram sachet of the modified therapeutic food formulation daily for 21 days. During the first 3 days, caregivers will divide the daily sachet into two approximately 15-gram servings. From Day 4 onward, the full daily amount may be given at one time or divided based on caregiver preference. |
| Nutri Listo SQ-LNS | Active comparator | Dietary Supplement: Nutri Listo SQ-LNSParticipants will receive one 30-gram sachet of Nutri Listo small-quantity lipid-based nutrient supplement daily for 21 days, with micronutrients adjusted for the study daily total. During the first 3 days, caregivers will divide the daily sachet into two approximately 15-gram servings. From Day 4 onward, the full daily amount may be given at one time or divided based on caregiver preference. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 12 to 24 months at enrollment
- Mild-to-moderate stunting, defined as height-for-age Z-score (HAZ) less than -1 and greater than -3
- Primary caregiver willing and able to provide informed consent
- Caregiver has access to a phone or WhatsApp, or has a trusted proxy such as a family member or neighbor who can assist with phone calls or WhatsApp communication
Key exclusion criteria (5 listed)
- Moderate or severe acute malnutrition, defined as weight-for-height Z-score (WHZ) less than -2
- Antibiotic use within the preceding 14 days
- Known food allergy or intolerance to study ingredients, including peanut, dairy, or egg
- History of persistent diarrhea, defined as watery stools lasting more than 7 consecutive days within the past month
- Caregiver report of frequent or severe abdominal distension or pain occurring shortly after consumption of fiber-rich foods
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 |
|---|---|---|
| Modified Therapeutic Food FormulationA nutrient-dense, food-based supplement packaged in single-use 30-gram sachets. The formulation includes green banana flour, chickpea flour, roasted peanut paste, high-oleic oil, whey protein concentrate, micronutrients, and other food ingredients. Participants receive 30 grams daily for 21 days. | Dietary supplement | Modified Therapeutic Food Formulation |
| Nutri Listo SQ-LNSAlso: Nutri ListoA commercially available small-quantity lipid-based nutrient supplement used in Guatemala for young children. For this study, Nutri Listo is provided in 30-gram sachets with the daily micronutrient amount adjusted for the study. Participants receive 30 grams daily for 21 days. | Dietary supplement | Nutri Listo SQ-LNS |
Primary outcome
Acceptability and palatability of the study product
Time frame: Initial taste test (Day 0) and endline assessment (Day 22)
Acceptability and palatability will be assessed using structured study questionnaires. During the initial taste test, staff will record the amount of modified therapeutic food consumed, observed feeding behavior, and whether the caregiver believes the child would eat the product every day. At endline, caregivers will rate overall acceptance of the assigned study product on a 4-point scale: refused most of the time (1), accepted with difficulty (2), accepted well (3), or liked it very much (4). Unabbreviated title: Therapeutic Acceptability Score. Range: 1 (worst) to 4 (best).
Adherence to daily study product consumption
Time frame: Days 1 through 21, with endline assessment on Day 22
Adherence will be assessed during scheduled WhatsApp or telephone monitoring contacts using caregiver reports of whether the child consumed all, some, or none of the assigned product. At endline, staff will count remaining sachets and collect used sachets or wrappers to estimate product consumption during the 21-day home-feeding period.
Frequency and severity of gastrointestinal symptoms
Time frame: Days 1 through 21
During scheduled monitoring contacts, caregivers will report gastrointestinal symptoms occurring since the previous contact, including stomach pain, diarrhea or loose stools, vomiting, and bloating or gas. Symptom severity will be recorded as none, mild, or severe, and the specific symptom type will be documented when symptoms are reported.
7 secondary outcomes
Change in fecal calprotectin concentration
Time frame: Baseline to endline (Day 22)
Change in fecal short-chain fatty acid concentrations
Time frame: Baseline to endline (Day 22)
Directional change in gut microbiome composition
Time frame: Baseline to endline (Day 22)
Fecal pH
Time frame: Baseline and endline (Day 22)
Fecal sIgA
Time frame: Baseline and endline (Day 22)
Fecal alpha-1-antitrypsin (A1AT)
Time frame: Baseline and endline (Day 22)
Fecal Reg1B
Time frame: Baseline and endline (Day 22)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie results reported in study publications will be made available to qualified researchers upon reasonable request, subject to applicable ethics, consent, privacy, and data-use requirements. De-identified microbiome sequencing data and limited non-identifying metadata will be deposited in an appropriate public repository when required by the journal or repository standards. Direct participant identifiers will not be shared.
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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.
Lee Gaeddert, PhD principal investigator
Wuqu' Kawoq, Maya Health Alliance
Wendy Rodriguez, MD principal investigator
Wuqu' Kawoq, Maya Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Therapeutic Food Formulation and Nutri Listo SQ-LNS in people with Stunting of Growth and Chronic Malnutrition, run by Wuqu' Kawoq, Maya Health Alliance at 1 site in Guatemala.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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 Guatemala. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee E Gaeddert, PhD (620-543-5246, Lee.Gaeddert@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and palatability of the study product (time frame: Initial taste test (Day 0) and endline assessment (Day 22)). The study lists 3 primary outcomes in all. 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 16 Oct 2026.