Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mediterranean Diet Adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 24 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
Mediterranean Diet Intervention
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.
干预措施: Mediterranean Diet Nutrition Program (Behavioral)
Standard Diet
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.
干预措施: Standard Diet Education Program (Behavioral)
结局指标
主要结局
Mediterranean Diet Adherence
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Gut Microbiome Diversity, Composition, and Metabolites(Baseline, at 3 weeks, and at 3 months after enrollment.)
- Toddler Anthropometrics, Body Composition, and Blood Pressure(Baseline, at 3 weeks, and at 3 months after enrollment.)
- Nutrition-Related Behaviors and Feeding Practices(Baseline, at 3 weeks, and at 3 months after enrollment.)
研究者
Maryam Kebbe
Associate Professor
University of New Brunswick