Obesity, Childhood Clinical Trial
Official title:
Effects of Early Introduction of Allergenic Foods Followed by Ad-libitum Consumption, on Food Allergic Sensitisation, Allergy and Measures of Child Health at 8 Years of Age in Exclusively Breastfed Infants
Verified date | March 2018 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The EAT Study showed a reduction in both sensitisation (to all foods) and clinical food allergy (to peanut and egg) among children who consumed allergenic food early compared with those who followed standard government feeding advice to exclusively consume breast milk for the first 6 months of life. The EAT-On Study aims to establish whether the effects seen at 3 years in the EAT study represent a delay in FA onset or sustained tolerance. EAT-On will also investigate the natural history (emergence and resolution) of FA in childhood; thus shaping dietary and management plans for allergic patients. Findings will inform future research and weaning recommendations for preventing FA.
Status | Enrolling by invitation |
Enrollment | 1235 |
Est. completion date | April 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 8 Years |
Eligibility |
Inclusion Criteria: - Previous participation in the EAT study - Age 8 years +/- 12 months Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Paediatric Allergy | London |
Lead Sponsor | Collaborator |
---|---|
King's College London | Action Medical Research |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Allergic sensitisation | Between group differences in total number of cumulative sensitisations to the six study food allergens at age 8 | 3 years | |
Primary | Food allergy | Between group differences in cumulative food allergy (challenge confirmed) t the six study foods at age 8 | 3 years | |
Primary | Child Health | Between group differences in proportion of children who classified as overweight or obese as determined by their BMI and/or BMI z score | 3 years | |
Secondary | Other allergic sensitisations | Between group differences in proportion of children with SPT sensitisation to additional food allergens (hazelnut, brazil nut, cashew, almond and walnut) and aero-allergens (timothy grass, birch pollen, house dust mite, cat and dog dander). | 3 years | |
Secondary | Mechanisms of allergy | Between group differences in specific IgE, IgG and IgG4 to peanut, egg, sesame and aeroallergens | 3 years | |
Secondary | Coeliac disease | Between group differences in prevalence of coeliac disease using coeliac antibody test (tTG IgA) screening test | 3 years | |
Secondary | Atopic dermatitis | Between group differences in prevalence of atopic dematitis | 3 years | |
Secondary | Allergic rhinoconjunctivitis | Between group differences in prevalence of seasonal and perennial rhinoconjunctivitis | 3 years | |
Secondary | Asthma | Between group differences in prevalence of asthma | 3 years | |
Secondary | Oral allergy syndrome | Between group differences in prevalence of oral allergy syndrome | 3 years | |
Secondary | Parent reported food allergy | Between group differences in food reaction history (parent-reported immediate onset food allergy) | 3 years | |
Secondary | Sibling allergies | Prevalence of sibling allergies (food allergies, eczema, asthma and rhinitis) | 3 years | |
Secondary | AGE Level in association with food allergies | Between group differences in AGE levels in association with food allergies | 3 years | |
Secondary | Skin fold thickness | Between group differences in skin fold thickness (triceps and subscapular) | 3 years | |
Secondary | Circumference measurements | Between group differences in midarm, waist and head circumference | 3 years | |
Secondary | Anthropometric ratios | Between group differences in; adjusted weight for height; waist; height ratio; height adjusted weight circumference | 3 years | |
Secondary | Fat free mass | Between group differences in fat free mass | 3 years | |
Secondary | Conicity index | Between group differences in conicity index (calculated from waist circumference and height and weight measurements) | 3 years | |
Secondary | Cardiovascular health | Between group differences in the proportion of children with cardiovascular measurements outside the expected range | 3 years | |
Secondary | Vascular stiffness | Between group differences in vascular stiffness | 3 years | |
Secondary | AGE | Between group differences in advanced glycation end products (AGE) | 3 years | |
Secondary | Inflammation | Between group differences in inflammation (measured using IL=6; sensitive CRP; TNF alpha; MCP-1; RANTES chemokine | 3 years | |
Secondary | Metabolic and endocrine | Between group differences in insulin, IGF-1 and leptin | 3 years | |
Secondary | White cell count | Between group differences in total white blood cell count | 3 years | |
Secondary | Macronutrient dietary intake | Between group differences in macronutrient intake | 3 years | |
Secondary | Dietary habits | Between group differences in fussy eating | 3 years | |
Secondary | Physical activity | Influence of physical activity on anthropometry and body composition measurements | 3 years | |
Secondary | Genetic influences | Influence of parental size on: height; weight; waist circumference on participant's size | 3 years |
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