Chronic MalnutritionSANTENCT07284095
Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo
A study testing Tenebrio Molitor powder in people with Chronic Malnutrition and Stunting of Growth, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Democratic Republic of the Congo.
Trial summary
The goal of this clinical trial is to evaluate whether a dietary supplement based on Tenebrio molitor (mealworm flour) can improve nutritional status and biomarkers of micronutrient deficiency in children aged 2-10 years. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Chronic Malnutrition, Stunting of Growth
- What is being tested?
- Tenebrio Molitor powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 1 Feb 2026to Aug 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with chronic malnutrition (weight-for-height or BMI below -2 SD according to WHO standards).
- Children whose families agree to participate in the intervention and sign the informed consent form.
Who cannot join
- Children with severe acute illnesses that may interfere with the intervention.
- Children with known allergies to the ingredients of the nutritional products provided.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Democratic Republic of the Congo1 site
Kesho Congo
Bukavu
Adolphe Nyakasane, Pediatritian, +243 820 422 427, adolphe.nyakasane@keshocongo.org
About this study
Official title: SANTE INITIATIVE: Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo
The goal of this clinical trial is to evaluate whether a dietary supplement based on Tenebrio molitor (mealworm flour) can improve nutritional status and biomarkers of micronutrient deficiency in children aged 2-10 years.
The main questions it aims to answer are:
Read more
- Does regular supplementation with Tenebrio molitor flour improve chronic malnutrition status
Researchers will compare the intervention group (children receiving Tenebrio molitor flour supplement) with the control group (children receiving a traditional maize-soy flour supplement) to assess differences in biochemical and anthropometric outcomes after the intervention period.
Participants will:
- Participate in baseline and follow-up anthropometric and blood sample assessments (hemoglobin, albumin, zinc, iron, calcium, magnesium, vitamin A, folic acid, vitamin B12, prealbumin).
- Consume a daily dietary supplement (either Tenebrio molitor flour or maize-soy flour) for the duration of the intervention.
- Provide information on dietary intake and general health status through structured questionnaires administered by the research team.
- Conditions
- Chronic Malnutrition, Stunting of Growth
- Being tested
- Tenebrio Molitor powder, Control Group (Maize-Soy supplement)
- Keywords
- Chronic Malnutrition, Stunting, Tenebrio Molitor, Food Security, Sustainable Foods
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenebrio Molitor powderDietary supplement
The intervention consists of a daily dietary supplement made from Tenebrio molito powder, a sustainable and high-protein insect. Each participant in the intervention group will receive a pre-measured daily dose of Tenebrio molitor The supplement is designed to improve protein quality and micronutrient intake, particularly iron, zinc, and vitamin B12, in children aged 2-10 years.
This intervention differs from traditional nutritional supplements by using Tenebrio molitor as a novel source of animal protein and micronutrients, contributing to sustainable food systems and child nutrition in low-resource settings.
Control Group (Maize-Soy supplement)Dietary supplement
The control supplement is a daily dietary mixture made from maize and soy flour, formulated to match the dose of the intervention supplement but without Tenebrio molitor protein. This preparation represents a conventional plant-based dietary supplement commonly used in nutritional support programs.
It serves as an active comparator to assess the added nutritional and functional benefits of Tenebrio molitor flour in improving biochemical and anthropometric indicators of child nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive a daily supplement made from Tenebrio molitor (mealworm) flour for 24 weeks. Receives: Dietary Supplement: Tenebrio Molitor powder |
| Control Group | Active comparator | Participants will receive a daily supplement made from maize and soy flour for 24 weeks. Receives: Dietary Supplement: Control Group (Maize-Soy supplement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prealbumin
Prealbumin levels will be measured to assess improvement in protein nutritional status among participants receiving Tenebrio molitor flour supplement compared with those receiving maize-soy flour supplement.
Measured: Baseline (Week 0) and 24 weeks of supplementation.
Height-for-Age z-scores (WHO Child Growth Standards)
To evaluate the effect of Tenebrio molitor supplementation on growth parameters in children. Scale range: z-scores less than or equal to -2 indicate stunting; less than or equal to -3 indicate severe stunting. Values close to 0 reflect adequate growth. High positive values (>+2 or >+3) indicate heights that are significantly above the average
Measured: Baseline, 12 weeks and 24 weeks
Secondary outcomes (7)
Change in Serum Iron Concentration (µg/dL)
To determine whether Tenebrio molitor flour improves serum iron levels compared to maize-soy flour.
Measured: From Baseline to 24 Weeks
Change in Serum Zinc Concentration (µg/dL)
To determine whether Tenebrio molitor flour improves serum Zinc levels compared to maize-soy flour.
Measured: From Baseline to 24 Weeks
Change in Serum Vitamin B12 Concentration (pg/mL)
To determine whether Tenebrio molitor flour improves serum Vitamin B12 levels compared to maize-soy flour.
Measured: From Baseline to 24 Weeks
Change in Serum Vitamin B9 (Folate) Concentration (µg/dL)
To determine whether Tenebrio molitor flour improves serum Vitamin B9 (Folate) levels compared to maize-soy flour.
Measured: From Baseline to 24 Weeks
Change in Serum Vitamin A Concentration (µg/dL)
To determine whether Tenebrio molitor flour improves serum Vitamin A levels compared to maize-soy flour.
Measured: From Baseline to 24 Weeks
Change in Serum Calcium Concentration (mg/dL)
To determine whether Tenebrio molitor flour improves serum Calcium levels compared to maize-soy flour.
Measured: From Baseline to 24 Weeks
Change in Serum Magnesium Concentration (mg/dL)
To determine whether Tenebrio molitor flour improves serum Magnesium levels compared to maize-soy flour.
Measured: From Baseline to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Amigos de Monkole
- Responsible party
- Sponsor
- Investigators
- Nerea Martín Calvo, Study director, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284095
- Sponsor's protocol ID
- SANTE
- Acronym
- SANTE
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SANTE INITIATIVE: Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo
- ClinicalTrials.gov ID
- NCT07284095
- Acronym / sponsor ID
- SANTE / SANTE
- Conditions
- Chronic Malnutrition, Stunting of Growth
- Keywords
- Chronic Malnutrition, Stunting, Tenebrio Molitor, Food Security, Sustainable Foods
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Fundación Amigos de Monkole
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 16 Dec 2025 (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 evaluate whether a dietary supplement based on Tenebrio molitor (mealworm flour) can improve nutritional status and biomarkers of micronutrient deficiency in children aged 2-10 years.
The main questions it aims to answer are:
- Does regular supplementation with Tenebrio molitor flour improve chronic malnutrition status
Researchers will compare the intervention group (children receiving Tenebrio molitor flour supplement) with the control group (children receiving a traditional maize-soy flour supplement) to assess differences in biochemical and anthropometric outcomes after the intervention period.
Participants will:
- Participate in baseline and follow-up anthropometric and blood sample assessments (hemoglobin, albumin, zinc, iron, calcium, magnesium, vitamin A, folic acid, vitamin B12, prealbumin).
- Consume a daily dietary supplement (either Tenebrio molitor flour or maize-soy flour) for the duration of the intervention.
- Provide information on dietary intake and general health status through structured questionnaires administered by the research team.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Tenebrio Molitor powderParticipants will receive a daily supplement made from Tenebrio molitor (mealworm) flour for 24 weeks. |
| Control Group | Active comparator | Dietary Supplement: Control Group (Maize-Soy supplement)Participants will receive a daily supplement made from maize and soy flour for 24 weeks. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children diagnosed with chronic malnutrition (weight-for-height or BMI below -2 SD according to WHO standards).
- Children whose families agree to participate in the intervention and sign the informed consent form.
Key exclusion criteria (2 listed)
- Children with severe acute illnesses that may interfere with the intervention.
- Children with known allergies to the ingredients of the nutritional products provided.
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 |
|---|---|---|
| Tenebrio Molitor powderThe intervention consists of a daily dietary supplement made from Tenebrio molito powder, a sustainable and high-protein insect. Each participant in the intervention group will receive a pre-measured daily dose of Tenebrio molitor The supplement is designed to improve protein quality and micronutrient intake, particularly iron, zinc, and vitamin B12, in children aged 2-10 years. This intervention differs from traditional nutritional supplements by using Tenebrio molitor as a novel source of animal protein and micronutrients, contributing to sustainable food systems and child nutrition in low-resource settings. | Dietary supplement | Intervention Group |
| Control Group (Maize-Soy supplement)The control supplement is a daily dietary mixture made from maize and soy flour, formulated to match the dose of the intervention supplement but without Tenebrio molitor protein. This preparation represents a conventional plant-based dietary supplement commonly used in nutritional support programs. It serves as an active comparator to assess the added nutritional and functional benefits of Tenebrio molitor flour in improving biochemical and anthropometric indicators of child nutrition. | Dietary supplement | Control Group |
Primary outcome
Prealbumin
Time frame: Baseline (Week 0) and 24 weeks of supplementation.
Prealbumin levels will be measured to assess improvement in protein nutritional status among participants receiving Tenebrio molitor flour supplement compared with those receiving maize-soy flour supplement.
Height-for-Age z-scores (WHO Child Growth Standards)
Time frame: Baseline, 12 weeks and 24 weeks
To evaluate the effect of Tenebrio molitor supplementation on growth parameters in children. Scale range: z-scores less than or equal to -2 indicate stunting; less than or equal to -3 indicate severe stunting. Values close to 0 reflect adequate growth. High positive values (>+2 or >+3) indicate heights that are significantly above the average
7 secondary outcomes
Change in Serum Iron Concentration (µg/dL)
Time frame: From Baseline to 24 Weeks
Change in Serum Zinc Concentration (µg/dL)
Time frame: From Baseline to 24 Weeks
Change in Serum Vitamin B12 Concentration (pg/mL)
Time frame: From Baseline to 24 Weeks
Change in Serum Vitamin B9 (Folate) Concentration (µg/dL)
Time frame: From Baseline to 24 Weeks
Change in Serum Vitamin A Concentration (µg/dL)
Time frame: From Baseline to 24 Weeks
Change in Serum Calcium Concentration (mg/dL)
Time frame: From Baseline to 24 Weeks
Change in Serum Magnesium Concentration (mg/dL)
Time frame: From Baseline to 24 Weeks
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 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Nerea Martín Calvo study director
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenebrio Molitor powder in people with Chronic Malnutrition and Stunting of Growth, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Democratic Republic of the Congo.
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 2 inclusion and 2 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 Dec 2025. 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 Democratic Republic of the Congo. 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 Nerea Martín Calvo, PhD (+34 629 34 79 56, nmartincalvo@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prealbumin (time frame: Baseline (Week 0) and 24 weeks of supplementation.). The study lists 2 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 Dec 2025.