Gut MicrobiomeMUNCHIESNCT07309536
Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES) Study
A study testing Mediterranean Diet Nutrition Program and Standard Diet Education Program in people with Gut Microbiome and Body Composition, run by University of New Brunswick at 1 site in Canada.
Trial summary
Toddlerhood (ages 2-3) is a critical window when the gut microbiome is still developing and eating habits are being established. Yet, many Canadian toddlers eat diets high in sugar and salt, which may affect long-term health. Read more about this study
- Who is it for?
- Ages 24 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Body Composition, Adherence
- What is being tested?
- Mediterranean Diet Nutrition Program and Standard Diet Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to 1 Nov 2027
- 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 24 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent is ≥19 years of age.
- Carried a singleton pregnancy.
- Delivered at term (≥37 weeks gestation).
- Delivered vaginally or by cesarean section.
- Infant was born with a birth weight between 2,500 g and 4,500 g.
- Toddler is between 24 and 36 months of age at enrollment.
Show all 10Show fewer
- Parent is able to communicate in English.
- Parent is willing to adhere to the Mediterranean diet for their toddler for 3 weeks.
- Parent is willing to participate in a nutrition education program for 3 months.
- Parent is willing to complete all measurements and provide a stool sample from their toddler.
Who cannot join
- Toddler has food allergies or dietary restrictions (e.g., gluten-free) that make it difficult to follow a Mediterranean diet.
- Toddler is at high risk for food allergies (e.g., strong family history of multiple food allergies common to the Mediterranean diet).
- Toddler is already following a Mediterranean diet.
- Toddler has had recent or active consumption of antibiotics, probiotics, or prebiotic drops.
- Toddler has an active acute illness, such as fever, diarrhea, or constipation.
- Toddler was born with a congenital illness or malformation that could affect diet, inflammation, gut health, or body composition.
- Toddler is currently breastfeeding, formula-feeding, or combination feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of New Brunswick
Fredericton, New Brunswick, E3B 4J9
Dr. Maryam Kebbe, PhD, CLC, 15064516872, maryam.kebbe@unb.ca
Dr. Maryam Kebbe, PhD, CLC
About this study
Official title: Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES): A Randomized Controlled Trial
Toddlerhood (ages 2-3) is a critical window when the gut microbiome is still developing and eating habits are being established. Yet, many Canadian toddlers eat diets high in sugar and salt, which may affect long-term health. This study will test whether a MED diet can improve dietary inflammation, gut health, and body composition in toddlers and whether a tailored nutrition education program for parents can help families maintain healthy eating patterns.
In this study, toddlers will be randomly assigned to a 3-week MED diet or their usual diet. Families in the MED diet group will receive free meal boxes for the 3 weeks, plus guidance from a nutrition researcher through a structured education program. The standard diet group will continue their regular diet with general nutrition advice. Researchers will collect dietary information, body composition assessments, and stool samples to measure gut microbiome composition and metabolites.
This first study of a controlled diet intervention in toddlers, combining behavioral support, high-quality food provision, and advanced gut microbiome analysis, will help understand how early diet shapes lifelong eating habits and health, guiding public health strategies and precision nutrition approaches to prevent chronic disease from early life.
Read the detailed description
The gut microbiome, central to immune and metabolic regulation, is highly responsive to dietary inputs. In adults, interventions like the Mediterranean (MED) diet rapidly increase beneficial microbial taxa and anti-inflammatory metabolites. Toddlerhood (24-36 months) represents a critical window when the gut microbiome continues to stabilize and dietary patterns become established. Yet, the diets of Canadian toddlers remain suboptimal, often dominated by high-sodium, high-sugar foods.
The aims of this study are to determine the effects of a (i) MED diet food-provision intervention on dietary inflammation, the gut microbiome and metabolites, and body composition of toddlers aged 2-3 years at 3 weeks and (ii) comprehensive, tailored nutrition education program, with or without food provision, in promoting adherence to the prescribed diets at 3 weeks and 3 months post-baseline.
This parallel randomized controlled trial at the University of New Brunswick will randomized parent-toddler dyads to either a 3-week MED diet or a Standard diet. Families in the MED diet group will receive free food provision and a tailored, theory-driven parental nutrition program. They will be provided with packaged food boxes including three meals (breakfast/lunch/dinner) and two snacks for each day of the week. Meals will be developed and prepared by a registered dietitian in UNB's metabolic kitchen under sterile conditions and delivered to parents in coolers. Families in the Standard diet group will continue to consume their regular diet and receive general nutrition education. Both groups will be initially screened using the KIDMED 2.0 to ensure they do not already adopt a MED diet. The nutrition education programs will be delivered over a 3-month period from baseline.
The primary outcome is the between-group difference in Children's Dietary Inflammatory Index scores at 3 weeks, diet adherence, and program satisfaction. Secondary outcomes include microbial diversity, taxa, metabolite profiles, body composition, blood pressure, and additional feeding metrics. Assessments will occur at baseline, 3 weeks, and 3 months. Stool samples will be analyzed using shallow shotgun metagenomics and metabolomics to assess microbial taxa, SCFAs, and other metabolites. Statistical analyses, conducted in R, will include t-tests, PERMANOVA, and mediation models.
The toddler years are a pivotal time for shaping lifelong eating habits and health outcomes, persisting into adolescence and adulthood. This is the first trial to test a controlled dietary intervention in toddlers, integrating behavioural theory and patient-oriented research. It will bring together a multifaceted team, combining expertise in nutrition and dietetics with cutting-edge knowledge in genomics for gut microbiome analysis. Findings will inform public health strategies and advance precision nutrition to reduce chronic disease risk from early life.
- Conditions
- Gut Microbiome, Body Composition, Adherence, Metabolites, Inflammation
- Being tested
- Mediterranean Diet Nutrition Program, Standard Diet Education Program
- Keywords
- Dietary patterns, Gastrointestinal microbiome, Body composition, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet Nutrition ProgramBehavioural
A nine session nutrition and feeding program designed to assess how a Mediterranean-style diet influences toddler gut health, body composition, and inflammation. Toddlers will receive Mediterranean-style foods for the first three weeks, followed by continued guidance through bi-weekly educational sessions focused on meal preparation, food variety, and adherence. Specifically sessions will cover key topics such as toddler nutrient needs, budget-friendly meal planning, picky eating, family mealtime strategies, and mindful eating. The program emphasizes incorporating fruits, vegetables, legumes, whole grains, and healthy fats into toddler meals, reducing ultra-processed foods, and promoting balanced feeding during early childhood.
Standard Diet Education ProgramBehavioural
A nine session general toddler nutrition education program designed to reflect typical dietary patterns in Canadian families. Families receive sessions on topics such as feeding styles, cultural foods and feeding practices, understanding nutrition labels, food safety, choking hazards and prevention, healthy recipes, myths and misinformation, and meal structure and routines. No study foods are provided. Toddlers maintain their usual diets throughout the study while completing the same measurements as those in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet Intervention | Experimental | Toddlers in this group will follow a Mediterranean-style diet for nine weeks. Families will receive Mediterranean diet foods for three weeks and take part in nine weekly sessions (one overview and eight follow-up sessions) focused on preparing toddler-appropriate Mediterranean meals. The sessions are designed to support consistency in feeding, track progress, and provide guidance on diet adherence. Measurements of toddler height, weight, body composition (BOD POD), stool samples, and questionnaires will be collected at baseline, 3 weeks, and 3 months post-baseline. Receives: Behavioral: Mediterranean Diet Nutrition Program |
| Standard Diet | Active comparator | Toddlers in this group will continue their usual diets for nine weeks while families participate in nine weekly general nutrition education sessions. Measurements of toddler height, weight, body composition (BODPOD), stool samples, and questionnaires will occur at the same time points as the intervention group. Families in this group will receive a $100 honorarium. Receives: Behavioral: Standard Diet Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mediterranean Diet Adherence
Adherence to the Mediterranean diet will be defined as the degree to which toddlers' and parents' food intake aligns with core Mediterranean diet principles (high intake of fruits, vegetables, legumes, whole grains, fish, and healthy fats; limited red meat, processed foods, and added sugars). Adherence will be assessed using the KIDMED 2.0 questionnaire for toddlers and a validated Mediterranean Diet Adherence Screener (MEDAS) for parents, weekly for the first 3 weeks and every two weeks for the remaining 9 weeks. Scores range from 0 to 12 for toddlers and 0 to 14 for parents, with higher scores indicating greater adherence.
Measured: Baseline, at 3 weeks, and at 3 months after enrollment.
Program Feasibility and Acceptability
Feasibility will be assessed via recruitment, retention, adherence to diet, attendance at nutrition sessions, and completion of study measures. Acceptability will be assessed through parent-reported satisfaction surveys regarding the diet and education program.
Measured: Ongoing throughout study (baseline to 3 months).
Children's Dietary Inflammatory Index (C-DII)
The Children's Dietary Inflammatory Index (C-DII) quantifies the inflammatory potential of an individual's diet. For this study, toddler dietary intake obtained from 24-hour dietary recalls (one weekday and one weekend per week for first 3 weeks, every two weeks for final 9 weeks) will be used to calculate C-DII scores. The DII scoring algorithm assigns weights to nutrient and food component intake based on their established inflammatory properties. Higher DII scores indicate more pro-inflammatory dietary patterns, whereas lower (more negative) scores represent more anti-inflammatory diets aligned with Mediterranean-style eating.
Measured: Baseline, at 3 weeks, and at 3 months after enrollment.
Secondary outcomes (3)
Gut Microbiome Diversity, Composition, and Metabolites
Gut microbiome diversity and taxa will be assessed using metagenomic sequencing of stool samples collected from toddlers. Alpha diversity metrics (e.g., Shannon index, Chao1) and beta diversity metrics (Bray-Curtis dissimilarity) will quantify within- and between-sample microbial diversity. Taxonomic composition at phylum, family, and genus levels will also be examined, as well as microbial metabolite profiles relevant to inflammation and metabolic regulation.
Measured: Baseline, at 3 weeks, and at 3 months after enrollment.
Toddler Anthropometrics, Body Composition, and Blood Pressure
Toddler growth and body composition will be assessed using standardized anthropometric and air-displacement plethysmography methods. Height and weight will be measured to calculate body mass index (BMI), which will then be converted to BMI-for-age percentiles and/or z-scores using WHO growth standards to characterize growth status. Waist circumference will be collected. Body composition will be evaluated using the BOD POD Pediatric Option, an air-displacement plethysmography system that provides estimates of fat mass, fat-free mass, and percentages. Together, these metrics will provide data on dietary patterns may impact growth and body composition. Blood pressure will be measured using a manual sphygmomanometer, which will provide additional indication of cardiovascular health and risk for hypertension-related conditions.
Measured: Baseline, at 3 weeks, and at 3 months after enrollment.
Nutrition-Related Behaviors and Feeding Practices
Parents' feeding practices and toddlers' eating behaviors will be assessed using validated self-report questionnaires, such as the Child Feeding Questionnaire (CFQ) and the Feeding Practices and Structure Questionnaire (FPSQ). Each instrument generates subscale scores by averaging item responses within each domain. For the CFQ, items are rated on 1-5 Likert scales, and subscales such as Restriction, Pressure to Eat, and Monitoring are calculated by averaging item scores; higher values indicate greater use of that feeding practice. For the FPSQ, items are also scored on Likert scales and grouped into Structure (e.g., routines, limits) and Autonomy Support (e.g., encouragement, involvement) subscales, with mean scores reflecting how frequently each practice is used. These procedures quantify parental control, responsiveness, feeding structure, and child eating behaviors (e.g., neophobia, appetite traits), offering a multidimensional profile of feeding dynamics.
Measured: Baseline, at 3 weeks, and at 3 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiomeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Kebbe, University of New Brunswick
- Investigators
- Dr. Maryam Kebbe, PhD, CLC, Principal investigator, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309536
- Sponsor's protocol ID
- 2025-146
- Acronym
- MUNCHIES
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kheirmandparizi M, Gouin JP, Bouchaud CC, Kebbe M, Bergeron C, Madani Civi R, Rhodes RE, Farnesi BC, Bouguila N, Conklin AI, Lear SA, Cohen TR. Perceptions of self-monitoring dietary intake according to a plate-based approach: A qualitative study. PLoS One. 2023 Nov 28;18(11):e0294652. doi: 10.1371/journal.pone.0294652. eCollection 2023.
PubMed 38015899Kebbe M, Leung K, Perrett B, Reimer RA, Adamo K, Redman LM. Effects of Infant Formula Supplemented With Prebiotics on the Gut Microbiome, Gut Environment, Growth Parameters, and Safety and Tolerance: A Systematic Review and Meta-Analysis. Nutr Rev. 2025 Mar 1;83(3):422-447. doi: 10.1093/nutrit/nuae184.
PubMed 39832301Redman LM, Phelan S, Apolzan JW, Beyl RA, Altazan AD, Dickey MS, Simeon E, Flanagan EW, Cabre HE, Sparks JR, Kebbe M, Caughey AB, Valent AM, Hsia DS, Yin E, Keadle SK. Protocol for a randomised controlled trial of a weight maintenance intervention to promote fat loss in pregnant individuals with obesity. BMJ Open. 2025 Feb 25;15(2):e095804. doi: 10.1136/bmjopen-2024-095804.
PubMed 40000086Kebbe M, Eaton A, Dyson M, Scott S, McHUGH T, Yaskina M, Ladha T, Islam B, Talwar K, Wincott J, Ball G. Testing the Feasibility, User Experiences, and Preliminary Effect of Conversation Cards for Adolescents(c) For Behavior Change and Collaborative Goal Setting in Primary Care: A Pilot Randomized Controlled Trial. J Health Commun. 2024 Oct 2;29(10):663-671. doi: 10.1080/10810730.2024.2411318. Epub 2024 Oct 7.
PubMed 39374045Song X, Yang K, Cheng C, Hu Q, Zhao F, Lu S, Long J, Yang H, Chen S. Higher dietary inflammatory index linked to increased risk of hypertension: a systematic review and dose-response meta-analysis. Eur J Clin Nutr. 2025 Jun;79(6):512-519. doi: 10.1038/s41430-024-01530-9. Epub 2024 Oct 24.
PubMed 39448814Chen GQ, Peng CL, Lian Y, Wang BW, Chen PY, Wang GP. Association Between Dietary Inflammatory Index and Mental Health: A Systematic Review and Dose-Response Meta-Analysis. Front Nutr. 2021 May 5;8:662357. doi: 10.3389/fnut.2021.662357. eCollection 2021.
PubMed 34026809Liu FH, Liu C, Gong TT, Gao S, Sun H, Jiang YT, Zhang JY, Zhang M, Gao C, Li XY, Zhao YH, Wu QJ. Dietary Inflammatory Index and Health Outcomes: An Umbrella Review of Systematic Review and Meta-Analyses of Observational Studies. Front Nutr. 2021 May 19;8:647122. doi: 10.3389/fnut.2021.647122. eCollection 2021.
PubMed 34095187Mayr HL, Thomas CJ, Tierney AC, Kucianski T, George ES, Ruiz-Canela M, Hebert JR, Shivappa N, Itsiopoulos C. Randomization to 6-month Mediterranean diet compared with a low-fat diet leads to improvement in Dietary Inflammatory Index scores in patients with coronary heart disease: the AUSMED Heart Trial. Nutr Res. 2018 Jul;55:94-107. doi: 10.1016/j.nutres.2018.04.006. Epub 2018 Apr 14.
PubMed 29754829Hurley KM, Pepper MR, Candelaria M, Wang Y, Caulfield LE, Latta L, Hager ER, Black MM. Systematic development and validation of a theory-based questionnaire to assess toddler feeding. J Nutr. 2013 Dec;143(12):2044-9. doi: 10.3945/jn.113.179846. Epub 2013 Sep 25.
PubMed 24068792Moroney C, O'Leary F, Flood VM. The Med-NKQ: A Reliable Mediterranean Diet Nutrition Knowledge Questionnaire for Cardiovascular Disease. Nutrients. 2021 Aug 25;13(9):2949. doi: 10.3390/nu13092949.
PubMed 34578825Zongrone AA, Menon P, Pelto GH, Habicht JP, Rasmussen KM, Constas MA, Vermeylen F, Khaled A, Saha KK, Stoltzfus RJ. The Pathways from a Behavior Change Communication Intervention to Infant and Young Child Feeding in Bangladesh Are Mediated and Potentiated by Maternal Self-Efficacy. J Nutr. 2018 Feb 1;148(2):259-266. doi: 10.1093/jn/nxx048.
PubMed 29490102Wang Z, Bergeron N, Levison BS, Li XS, Chiu S, Jia X, Koeth RA, Li L, Wu Y, Tang WHW, Krauss RM, Hazen SL. Impact of chronic dietary red meat, white meat, or non-meat protein on trimethylamine N-oxide metabolism and renal excretion in healthy men and women. Eur Heart J. 2019 Feb 14;40(7):583-594. doi: 10.1093/eurheartj/ehy799.
PubMed 30535398Beckman JA, Shibao CA. Trimethylamine-N-Oxide, More Red Meat for the Vascular Scientists. Hypertension. 2020 Jul;76(1):40-41. doi: 10.1161/HYPERTENSIONAHA.120.14857. Epub 2020 Jun 10. No abstract available.
PubMed 32520618Leung AK, Marchand V, Sauve RS; Canadian Paediatric Society, Nutrition and Gastroenterology Committee. The 'picky eater': The toddler or preschooler who does not eat. Paediatr Child Health. 2012 Oct;17(8):455-60. doi: 10.1093/pch/17.8.455.
PubMed 24082809Davis C, Bryan J, Hodgson J, Murphy K. Definition of the Mediterranean Diet; a Literature Review. Nutrients. 2015 Nov 5;7(11):9139-53. doi: 10.3390/nu7115459.
PubMed 26556369
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07309536
- Acronym / sponsor ID
- MUNCHIES / 2025-146
- Conditions
- Gut Microbiome, Body Composition, Adherence, Metabolites, Inflammation
- Keywords
- Dietary patterns, Gastrointestinal microbiome, Body composition, Inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 30 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.
Toddlerhood (ages 2-3) is a critical window when the gut microbiome is still developing and eating habits are being established. Yet, many Canadian toddlers eat diets high in sugar and salt, which may affect long-term health. This study will test whether a MED diet can improve dietary inflammation, gut health, and body composition in toddlers and whether a tailored nutrition education program for parents can help families maintain healthy eating patterns.
In this study, toddlers will be randomly assigned to a 3-week MED diet or their usual diet. Families in the MED diet group will receive free meal boxes for the 3 weeks, plus guidance from a nutrition researcher through a structured education program. The standard diet group will continue their regular diet with general nutrition advice. Researchers will collect dietary information, body composition assessments, and stool samples to measure gut microbiome composition and metabolites.
This first study of a controlled diet intervention in toddlers, combining behavioral support, high-quality food provision, and advanced gut microbiome analysis, will help understand how early diet shapes lifelong eating habits and health, guiding public health strategies and precision nutrition approaches to prevent chronic disease from early life.
Detailed description
The gut microbiome, central to immune and metabolic regulation, is highly responsive to dietary inputs. In adults, interventions like the Mediterranean (MED) diet rapidly increase beneficial microbial taxa and anti-inflammatory metabolites. Toddlerhood (24-36 months) represents a critical window when the gut microbiome continues to stabilize and dietary patterns become established. Yet, the diets of Canadian toddlers remain suboptimal, often dominated by high-sodium, high-sugar foods.
The aims of this study are to determine the effects of a (i) MED diet food-provision intervention on dietary inflammation, the gut microbiome and metabolites, and body composition of toddlers aged 2-3 years at 3 weeks and (ii) comprehensive, tailored nutrition education program, with or without food provision, in promoting adherence to the prescribed diets at 3 weeks and 3 months post-baseline.
This parallel randomized controlled trial at the University of New Brunswick will randomized parent-toddler dyads to either a 3-week MED diet or a Standard diet. Families in the MED diet group will receive free food provision and a tailored, theory-driven parental nutrition program. They will be provided with packaged food boxes including three meals (breakfast/lunch/dinner) and two snacks for each day of the week. Meals will be developed and prepared by a registered dietitian in UNB's metabolic kitchen under sterile conditions and delivered to parents in coolers. Families in the Standard diet group will continue to consume their regular diet and receive general nutrition education. Both groups will be initially screened using the KIDMED 2.0 to ensure they do not already adopt a MED diet. The nutrition education programs will be delivered over a 3-month period from baseline.
The primary outcome is the between-group difference in Children's Dietary Inflammatory Index scores at 3 weeks, diet adherence, and program satisfaction. Secondary outcomes include microbial diversity, taxa, metabolite profiles, body composition, blood pressure, and additional feeding metrics. Assessments will occur at baseline, 3 weeks, and 3 months. Stool samples will be analyzed using shallow shotgun metagenomics and metabolomics to assess microbial taxa, SCFAs, and other metabolites. Statistical analyses, conducted in R, will include t-tests, PERMANOVA, and mediation models.
The toddler years are a pivotal time for shaping lifelong eating habits and health outcomes, persisting into adolescence and adulthood. This is the first trial to test a controlled dietary intervention in toddlers, integrating behavioural theory and patient-oriented research. It will bring together a multifaceted team, combining expertise in nutrition and dietetics with cutting-edge knowledge in genomics for gut microbiome analysis. Findings will inform public health strategies and advance precision nutrition to reduce chronic disease risk from early life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Intervention | Experimental | Behavioral: Mediterranean Diet Nutrition ProgramToddlers in this group will follow a Mediterranean-style diet for nine weeks. Families will receive Mediterranean diet foods for three weeks and take part in nine weekly sessions (one overview and eight follow-up sessions) focused on preparing toddler-appropriate Mediterranean meals. The sessions are designed to support consistency in feeding, track progress, and provide guidance on diet adherence. Measurements of toddler height, weight, body composition (BOD POD), stool samples, and questionnaires will be collected at baseline, 3 weeks, and 3 months post-baseline. |
| Standard Diet | Active comparator | Behavioral: Standard Diet Education ProgramToddlers in this group will continue their usual diets for nine weeks while families participate in nine weekly general nutrition education sessions. Measurements of toddler height, weight, body composition (BODPOD), stool samples, and questionnaires will occur at the same time points as the intervention group. Families in this group will receive a $100 honorarium. |
Who may qualify
- Ages
- 24 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Parent is ≥19 years of age.
- Carried a singleton pregnancy.
- Delivered at term (≥37 weeks gestation).
- Delivered vaginally or by cesarean section.
- Infant was born with a birth weight between 2,500 g and 4,500 g.
Key exclusion criteria (7 listed)
- Toddler has food allergies or dietary restrictions (e.g., gluten-free) that make it difficult to follow a Mediterranean diet.
- Toddler is at high risk for food allergies (e.g., strong family history of multiple food allergies common to the Mediterranean diet).
- Toddler is already following a Mediterranean diet.
- Toddler has had recent or active consumption of antibiotics, probiotics, or prebiotic drops.
- Toddler has an active acute illness, such as fever, diarrhea, or constipation.
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 |
|---|---|---|
| Mediterranean Diet Nutrition ProgramA nine session nutrition and feeding program designed to assess how a Mediterranean-style diet influences toddler gut health, body composition, and inflammation. Toddlers will receive Mediterranean-style foods for the first three weeks, followed by continued guidance through bi-weekly educational sessions focused on meal preparation, food variety, and adherence. Specifically sessions will cover key topics such as toddler nutrient needs, budget-friendly meal planning, picky eating, family mealtime strategies, and mindful eating. The program emphasizes incorporating fruits, vegetables, legumes, whole grains, and healthy fats into toddler meals, reducing ultra-processed foods, and promoting balanced feeding during early childhood. | Behavioural | Mediterranean Diet Intervention |
| Standard Diet Education ProgramA nine session general toddler nutrition education program designed to reflect typical dietary patterns in Canadian families. Families receive sessions on topics such as feeding styles, cultural foods and feeding practices, understanding nutrition labels, food safety, choking hazards and prevention, healthy recipes, myths and misinformation, and meal structure and routines. No study foods are provided. Toddlers maintain their usual diets throughout the study while completing the same measurements as those in the intervention group. | Behavioural | Standard Diet |
Primary outcome
Mediterranean Diet Adherence
Time frame: Baseline, at 3 weeks, and at 3 months after enrollment.
Adherence to the Mediterranean diet will be defined as the degree to which toddlers' and parents' food intake aligns with core Mediterranean diet principles (high intake of fruits, vegetables, legumes, whole grains, fish, and healthy fats; limited red meat, processed foods, and added sugars). Adherence will be assessed using the KIDMED 2.0 questionnaire for toddlers and a validated Mediterranean Diet Adherence Screener (MEDAS) for parents, weekly for the first 3 weeks and every two weeks for the remaining 9 weeks. Scores range from 0 to 12 for toddlers and 0 to 14 for parents, with higher scores indicating greater adherence.
Program Feasibility and Acceptability
Time frame: Ongoing throughout study (baseline to 3 months).
Feasibility will be assessed via recruitment, retention, adherence to diet, attendance at nutrition sessions, and completion of study measures. Acceptability will be assessed through parent-reported satisfaction surveys regarding the diet and education program.
Children's Dietary Inflammatory Index (C-DII)
Time frame: Baseline, at 3 weeks, and at 3 months after enrollment.
The Children's Dietary Inflammatory Index (C-DII) quantifies the inflammatory potential of an individual's diet. For this study, toddler dietary intake obtained from 24-hour dietary recalls (one weekday and one weekend per week for first 3 weeks, every two weeks for final 9 weeks) will be used to calculate C-DII scores. The DII scoring algorithm assigns weights to nutrient and food component intake based on their established inflammatory properties. Higher DII scores indicate more pro-inflammatory dietary patterns, whereas lower (more negative) scores represent more anti-inflammatory diets aligned with Mediterranean-style eating.
3 secondary outcomes
Gut Microbiome Diversity, Composition, and Metabolites
Time frame: Baseline, at 3 weeks, and at 3 months after enrollment.
Toddler Anthropometrics, Body Composition, and Blood Pressure
Time frame: Baseline, at 3 weeks, and at 3 months after enrollment.
Nutrition-Related Behaviors and Feeding Practices
Time frame: Baseline, at 3 weeks, and at 3 months after enrollment.
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 25 Sep 2026.
- Background: PubMed 38015899Kheirmandparizi M, Gouin JP, Bouchaud CC, Kebbe M, Bergeron C, Madani Civi R, Rhodes RE, Farnesi BC, Bouguila N, Conklin AI, Lear SA, Cohen TR. Perceptions of self-monitoring dietary intake according to a plate-based approach: A qualitative study. PLoS One. 2023 Nov 28;18(11):e0294652. doi: 10.1371/journal.pone.0294652. eCollection 2023.
- Background: PubMed 39832301Kebbe M, Leung K, Perrett B, Reimer RA, Adamo K, Redman LM. Effects of Infant Formula Supplemented With Prebiotics on the Gut Microbiome, Gut Environment, Growth Parameters, and Safety and Tolerance: A Systematic Review and Meta-Analysis. Nutr Rev. 2025 Mar 1;83(3):422-447. doi: 10.1093/nutrit/nuae184.
- Background: PubMed 40000086Redman LM, Phelan S, Apolzan JW, Beyl RA, Altazan AD, Dickey MS, Simeon E, Flanagan EW, Cabre HE, Sparks JR, Kebbe M, Caughey AB, Valent AM, Hsia DS, Yin E, Keadle SK. Protocol for a randomised controlled trial of a weight maintenance intervention to promote fat loss in pregnant individuals with obesity. BMJ Open. 2025 Feb 25;15(2):e095804. doi: 10.1136/bmjopen-2024-095804.
- Background: PubMed 39374045Kebbe M, Eaton A, Dyson M, Scott S, McHUGH T, Yaskina M, Ladha T, Islam B, Talwar K, Wincott J, Ball G. Testing the Feasibility, User Experiences, and Preliminary Effect of Conversation Cards for Adolescents(c) For Behavior Change and Collaborative Goal Setting in Primary Care: A Pilot Randomized Controlled Trial. J Health Commun. 2024 Oct 2;29(10):663-671. doi: 10.1080/10810730.2024.2411318. Epub 2024 Oct 7.
- Background: PubMed 39448814Song X, Yang K, Cheng C, Hu Q, Zhao F, Lu S, Long J, Yang H, Chen S. Higher dietary inflammatory index linked to increased risk of hypertension: a systematic review and dose-response meta-analysis. Eur J Clin Nutr. 2025 Jun;79(6):512-519. doi: 10.1038/s41430-024-01530-9. Epub 2024 Oct 24.
- Background: PubMed 34026809Chen GQ, Peng CL, Lian Y, Wang BW, Chen PY, Wang GP. Association Between Dietary Inflammatory Index and Mental Health: A Systematic Review and Dose-Response Meta-Analysis. Front Nutr. 2021 May 5;8:662357. doi: 10.3389/fnut.2021.662357. eCollection 2021.
- Background: PubMed 34095187Liu FH, Liu C, Gong TT, Gao S, Sun H, Jiang YT, Zhang JY, Zhang M, Gao C, Li XY, Zhao YH, Wu QJ. Dietary Inflammatory Index and Health Outcomes: An Umbrella Review of Systematic Review and Meta-Analyses of Observational Studies. Front Nutr. 2021 May 19;8:647122. doi: 10.3389/fnut.2021.647122. eCollection 2021.
- Background: PubMed 29754829Mayr HL, Thomas CJ, Tierney AC, Kucianski T, George ES, Ruiz-Canela M, Hebert JR, Shivappa N, Itsiopoulos C. Randomization to 6-month Mediterranean diet compared with a low-fat diet leads to improvement in Dietary Inflammatory Index scores in patients with coronary heart disease: the AUSMED Heart Trial. Nutr Res. 2018 Jul;55:94-107. doi: 10.1016/j.nutres.2018.04.006. Epub 2018 Apr 14.
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- Kebbe M. Nutribiomes Youtube Channel.Link provided by the sponsor.
- World Health Organization. (2018). Noncommunicable diseases fact sheet.Link provided by the sponsor.
- Statistics Canada. (2020). Leading causes of death, total population, by age group. Accessed August 20, 2024.Link provided by the sponsor.
- 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.
Dr. Maryam Kebbe, PhD, CLC principal investigator
University of New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet Nutrition Program and Standard Diet Education Program in people with Gut Microbiome and Body Composition, run by University of New Brunswick at 1 site in Canada.
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 10 inclusion and 7 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 25 Sep 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 Canada. 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 Dr. Maryam Kebbe, PhD, CLC (15064516872, maryam.kebbe@unb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mediterranean Diet Adherence (time frame: Baseline, at 3 weeks, and at 3 months after enrollment.). 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?
On the ClinicalTrials.gov record for NCT07309536, which also lists 33 linked publications.
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 25 Sep 2026.