xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06002620</url>
    </required_header>
    <id_info>
      <org_study_id>WP2 HEALTHYNSECT</org_study_id>
      <nct_id>NCT06002620</nct_id>
    </id_info>
    <brief_title>Healthynsect Child Growth and Health Intervention Study</brief_title>
    <acronym>HEALTHYNSECT</acronym>
    <official_title>Effect of Cricket Enriched Porridge and Nutrition Education on Stunting, Gut Health and Breastmilk Intake of Infants and Young Children in Western Kenya</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Copenhagen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Masinde Muliro University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Jomo Kenyatta University of Agriculture and Technology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Copenhagen</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Malnutrition in all its forms is still a problem in resource limited settings including Kenya&#xD;
        driven by low diet quality, food preparation and feeding practices including hygiene. Edible&#xD;
        insects are currently of interest in alleviating malnutrition due to their energy density,&#xD;
        high protein, vitamins and micronutrients (iron, zinc). Among the insects of preference are&#xD;
        the crickets which have been shown to encourage the growth of probiotics (Bifidobacterium&#xD;
        animalis) which support gut health increasing nutrient absorption and reduces systemic&#xD;
        inflammation. Despite the nutritional value of insects and the contribution of cricket to&#xD;
        improved gut health, there is limited evidence on the benefit of cricket based complementary&#xD;
        food in the reduction of stunting amongst infants and young children. This study aim to&#xD;
        determine the effect of integrating two nutrition interventions (cricket enriched porridge&#xD;
        with nutrition education) on the infant and young child growth (stunting) and gut health in&#xD;
        Alego Usonga Sub-County in Siaya County of rural western part of Kenya.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Malnutrition in all its forms is still prevalent in resource limited settings driven by low&#xD;
        diet quality, food preparation and feeding practices including hygiene. Untreated early&#xD;
        childhood malnutrition deprives the child from living to full potential, by increasing&#xD;
        susceptibility to childhood infections and is life threatening. Insects are currently of&#xD;
        interest in alleviating malnutrition due to their energy density, high protein, vitamins and&#xD;
        micronutrients (iron, zinc). Crickets positively support growth of probiotics&#xD;
        (Bifidobacterium animalis) which support gut health increasing nutrient absorption and&#xD;
        reduces systemic inflammation. Single nutrition interventions are confirmed to be less&#xD;
        effective in reducing malnutrition and stunting in particular, with a combination of&#xD;
        nutrition-specific and nutrition-sensitive interventions yielding better outcome. In spite of&#xD;
        recognizing nutritional value of insects and the contribution of cricket to improved gut&#xD;
        health, there is limited evidence on the benefit of cricket based complementary food in&#xD;
        reducing stunting amongst infants and young children. This study aims to determine the effect&#xD;
        of integrating two nutrition interventions (cricket enriched porridge with nutrition&#xD;
        education) on the infant and young child growth (stunting status) and gut health in rural&#xD;
        Kenya; Alego Usonga Sub-County in Siaya County. The study is based on a 2x2 factorial design&#xD;
        among infants aged 6 months and target to assess the main and combined effect of the two&#xD;
        interventions (nutrition education and cricket enriched porridge) on the infant and young&#xD;
        child's stunting and gut health. The study has four arms namely: Control arm (CA) where the&#xD;
        study participants receive the standard care comprising of the supercereal Corn Soy Blend&#xD;
        Plus (CSB+) in amounts adjusted for age, Enriched nutrition arm (ENA) where they receive the&#xD;
        improved complementary food enriched with cricket and optimized for all the benefits of the&#xD;
        cricket in amounts adjusted for age, Nutrition education arm (NEdA) where they receive&#xD;
        nutrition education and a Combined Nutrition Education and enriched nutrition (CEdNA). The&#xD;
        required sample size (based on the following parameters: Number of groups: = 4, effect size =&#xD;
        0.2, significance level = 0.05, power of test = 80%) is 70 study participants per study arm&#xD;
        yielding a total of 280.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 9, 2023</start_date>
    <completion_date type="Anticipated">January 16, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 16, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Factorial Assignment</intervention_model>
      <intervention_model_description>The study has four study arms namely: Control arm (CA), Enriched nutrition arm (ENA), Nutrition education arm (NEdA) and a Combined Nutrition Education and enriched nutrition (CEdNA).&#xD;
  Cricket Enriched flour(CEF) - with cricket, maize, millet, mineral and vitamin premix Corn-Soy Blend plus(CSB+) - with mineral and vitamin premix Nutrition Education- with video, face to face session and SMS reminder</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Stratified by sex, randomization was done by a team not participating in the study implementation and the randomization scheme sent directly to the assigned distribution staff The products under investigation are packed in similar containers differentiated by a code number only known to the distribution staff who is equally blinded of the products contents.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Stunting (Height/Length for age Z scores)</measure>
      <time_frame>8 months</time_frame>
      <description>Children who are too short for their age according to WHO 2005 growth standards. Length/Height in cm and age in months will be converted to Z scores using WHO Anthro and the values used to categorize growth as per the WHO 2005 standards</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Gut health</measure>
      <time_frame>Baseline</time_frame>
      <description>the integrity of the gut measured from stool illustrated by the gut microbiota(microbiome),Myeloperoxidase enzyme levels(MPO) as indicator of tissue inflammation plus butyrate concentration, alpha-1-anti trypsin (ATT) and Neopterin (NEO) &amp; and 13C stable isotope breath test measured by the time it takes to recover 50% of the stable isotope and also the amount of carbon dioxide produced in the first 90 minutes after the dose with the 13Carbon stable isotope</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary intake</measure>
      <time_frame>Baseline for breast milk intake, monthly for 8 months for the rest of the dietary intake information</time_frame>
      <description>Total dietary intake including breast milk intake measured by deuterium oxide technique</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">280</enrollment>
    <condition>Nutrition Status</condition>
    <arm_group>
      <arm_group_label>Control arm (CA)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A positive control group using an existing nutritional intervention with the known effect will be adopted, so as to meet ethical practice and be able to determine the effect of our new intervention response on the experimental group. The study will use double blinded approach with the control group receiving standard known flour of the supercereal CSB+ adjusted for ages as follows:6-8 months infants receiving 31g daily,9-11 months receiving 47g and 12-24 months receiving 86g to supply 200,300 and 550KCal daily respectively, with both the caregiver and person administering the food will be blinded from the content of the flour.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Enriched nutrition arm (ENA)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The study will use a Cricket Enriched flour(CEF) - with 20% cricket (, maize, millet, mineral and vitamin premix with amounts served adjusted to ages as:6-8 months infants receiving 29g daily,9-11 months receiving 44g and 12-24 months receiving 80g to supply 200,300 and 550KCal daily respectively, with both the caregiver and person administering the food will be blinded from the content of the flour.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nutrition education arm (NEdA)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Combines the control and nutrition education where nutrition education comprises of a video, face to face session and SMS reminder in predetermined regular sessions</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Combined Nutrition Education and enriched nutrition (CEdNA)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Combines the Cricket Enriched flour(CEF) and Nutrition education</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>CSB+</intervention_name>
      <description>standard care</description>
      <arm_group_label>Control arm (CA)</arm_group_label>
      <arm_group_label>Nutrition education arm (NEdA)</arm_group_label>
      <other_name>Standard care</other_name>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Enriched nutrition food (CEF)</intervention_name>
      <description>enriched cricket flour at 20%</description>
      <arm_group_label>Combined Nutrition Education and enriched nutrition (CEdNA)</arm_group_label>
      <arm_group_label>Enriched nutrition arm (ENA)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Nutrition education</intervention_name>
      <description>regular videos, sms reminders and face to face interaction</description>
      <arm_group_label>Nutrition education arm (NEdA)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Combined nutrition and education</intervention_name>
      <description>combined enriched cricket flour and nutrition education</description>
      <arm_group_label>Combined Nutrition Education and enriched nutrition (CEdNA)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged 6 months at the time of enrolment,&#xD;
  &#xD;
            2. Hemoglobin (Hb) of ≥7 g/dl (not severely anemic) and&#xD;
  &#xD;
            3. Height for Age (HAZ) ≥-3 Z scores (not severely stunted).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Those obviously ill and need medical attention who are referred for care as per&#xD;
               ministry of health protocol&#xD;
  &#xD;
            2. Children strictly fed on formula feed with no breast feeding&#xD;
  &#xD;
            3. Infants whose caregivers do not consent or don't commit to adhere to the feeding&#xD;
               regimen prescribed&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>7 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Silvenus O. Konyole, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Masinde Muliro University of Science and Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nanna Roos, PhD</last_name>
      <phone>+4535332497</phone>
      <email>nro@nexs.ku.dk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Rwambwa Sub County Hospital</name>
        <address>
          <city>Siaya</city>
          <state>Western</state>
          <zip>40600</zip>
          <country>Kenya</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Silah Oluoch, MBChB</last_name>
        <phone>+254 724596259</phone>
      </contact>
      <investigator>
        <last_name>Nicky O. Okeyo, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Kenya</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cricket</keyword>
    <keyword>insect</keyword>
    <keyword>complementary feeding</keyword>
    <keyword>gut health</keyword>
    <keyword>breastmilk intake</keyword>
    <keyword>13C sucrose breath test</keyword>
    <keyword>deuterium oxide</keyword>
    <keyword>stable isotopes</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06002620
  org study id: WP2 HEALTHYNSECT
  nct id: NCT06002620
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Malnutrition in all its forms is still a problem in resource limited settings including Kenya
        driven by low diet quality, food preparation and feeding practices including hygiene. Edible
        insects are currently of interest in alleviating malnutrition due to their energy density,
        high protein, vitamins and micronutrients (iron, zinc). Among the insects of preference are
        the crickets which have been shown to encourage the growth of probiotics (Bifidobacterium
        animalis) which support gut health increasing nutrient absorption and reduces systemic
        inflammation. Despite the nutritional value of insects and the contribution of cricket to
        improved gut health, there is limited evidence on the benefit of cricket based complementary
        food in the reduction of stunting amongst infants and young children. This study aim to
        determine the effect of integrating two nutrition interventions (cricket enriched porridge
        with nutrition education) on the infant and young child growth (stunting) and gut health in
        Alego Usonga Sub-County in Siaya County of rural western part of Kenya.
  Malnutrition in all its forms is still prevalent in resource limited settings driven by low
        diet quality, food preparation and feeding practices including hygiene. Untreated early
        childhood malnutrition deprives the child from living to full potential, by increasing
        susceptibility to childhood infections and is life threatening. Insects are currently of
        interest in alleviating malnutrition due to their energy density, high protein, vitamins and
        micronutrients (iron, zinc). Crickets positively support growth of probiotics
        (Bifidobacterium animalis) which support gut health increasing nutrient absorption and
        reduces systemic inflammation. Single nutrition interventions are confirmed to be less
        effective in reducing malnutrition and stunting in particular, with a combination of
        nutrition-specific and nutrition-sensitive interventions yielding better outcome. In spite of
        recognizing nutritional value of insects and the contribution of cricket to improved gut
        health, there is limited evidence on the benefit of cricket based complementary food in
        reducing stunting amongst infants and young children. This study aims to determine the effect
        of integrating two nutrition interventions (cricket enriched porridge with nutrition
        education) on the infant and young child growth (stunting status) and gut health in rural
        Kenya; Alego Usonga Sub-County in Siaya County. The study is based on a 2x2 factorial design
        among infants aged 6 months and target to assess the main and combined effect of the two
        interventions (nutrition education and cricket enriched porridge) on the infant and young
        child's stunting and gut health. The study has four arms namely: Control arm (CA) where the
        study participants receive the standard care comprising of the supercereal Corn Soy Blend
        Plus (CSB+) in amounts adjusted for age, Enriched nutrition arm (ENA) where they receive the
        improved complementary food enriched with cricket and optimized for all the benefits of the
        cricket in amounts adjusted for age, Nutrition education arm (NEdA) where they receive
        nutrition education and a Combined Nutrition Education and enriched nutrition (CEdNA). The
        required sample size (based on the following parameters: Number of groups: = 4, effect size =
        0.2, significance level = 0.05, power of test = 80%) is 70 study participants per study arm
        yielding a total of 280.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: The study has four study arms namely: Control arm (CA), Enriched nutrition arm (ENA), Nutrition education arm (NEdA) and a Combined Nutrition Education and enriched nutrition (CEdNA).
  Cricket Enriched flour(CEF) - with cricket, maize, millet, mineral and vitamin premix Corn-Soy Blend plus(CSB+) - with mineral and vitamin premix Nutrition Education- with video, face to face session and SMS reminder
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Stratified by sex, randomization was done by a team not participating in the study implementation and the randomization scheme sent directly to the assigned distribution staff The products under investigation are packed in similar containers differentiated by a code number only known to the distribution staff who is equally blinded of the products contents.
  measure: Stunting (Height/Length for age Z scores)
  time frame: 8 months
  description: Children who are too short for their age according to WHO 2005 growth standards. Length/Height in cm and age in months will be converted to Z scores using WHO Anthro and the values used to categorize growth as per the WHO 2005 standards
  measure: Gut health
  time frame: Baseline
  description: the integrity of the gut measured from stool illustrated by the gut microbiota(microbiome),Myeloperoxidase enzyme levels(MPO) as indicator of tissue inflammation plus butyrate concentration, alpha-1-anti trypsin (ATT) and Neopterin (NEO) & and 13C stable isotope breath test measured by the time it takes to recover 50% of the stable isotope and also the amount of carbon dioxide produced in the first 90 minutes after the dose with the 13Carbon stable isotope
  measure: Dietary intake
  time frame: Baseline for breast milk intake, monthly for 8 months for the rest of the dietary intake information
  description: Total dietary intake including breast milk intake measured by deuterium oxide technique
  arm group label: Control arm (CA)
  arm group type: Experimental
  description: A positive control group using an existing nutritional intervention with the known effect will be adopted, so as to meet ethical practice and be able to determine the effect of our new intervention response on the experimental group. The study will use double blinded approach with the control group receiving standard known flour of the supercereal CSB+ adjusted for ages as follows:6-8 months infants receiving 31g daily,9-11 months receiving 47g and 12-24 months receiving 86g to supply 200,300 and 550KCal daily respectively, with both the caregiver and person administering the food will be blinded from the content of the flour.
  arm group label: Enriched nutrition arm (ENA)
  arm group type: Experimental
  description: The study will use a Cricket Enriched flour(CEF) - with 20% cricket (, maize, millet, mineral and vitamin premix with amounts served adjusted to ages as:6-8 months infants receiving 29g daily,9-11 months receiving 44g and 12-24 months receiving 80g to supply 200,300 and 550KCal daily respectively, with both the caregiver and person administering the food will be blinded from the content of the flour.
  arm group label: Nutrition education arm (NEdA)
  arm group type: Experimental
  description: Combines the control and nutrition education where nutrition education comprises of a video, face to face session and SMS reminder in predetermined regular sessions
  arm group label: Combined Nutrition Education and enriched nutrition (CEdNA)
  arm group type: Experimental
  description: Combines the Cricket Enriched flour(CEF) and Nutrition education
  intervention type: Dietary Supplement
  intervention name: CSB+
  description: standard care
  arm group label: Control arm (CA)
  arm group label: Nutrition education arm (NEdA)
  other name: Standard care
  intervention type: Dietary Supplement
  intervention name: Enriched nutrition food (CEF)
  description: enriched cricket flour at 20%
  arm group label: Combined Nutrition Education and enriched nutrition (CEdNA)
  arm group label: Enriched nutrition arm (ENA)
  intervention type: Behavioral
  intervention name: Nutrition education
  description: regular videos, sms reminders and face to face interaction
  arm group label: Nutrition education arm (NEdA)
  intervention type: Combination Product
  intervention name: Combined nutrition and education
  description: combined enriched cricket flour and nutrition education
  arm group label: Combined Nutrition Education and enriched nutrition (CEdNA)
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 7 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Silvenus O. Konyole, PhD
  role: Principal Investigator
  affiliation: Masinde Muliro University of Science and Technology
  last name: Nanna Roos, PhD
  phone: +4535332497
  email: nro@nexs.ku.dk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Kenya
  responsible party type: Sponsor