Nutrition and lifestyle Nutritional, Metabolic, Endocrine
Conditions
Interventions
The personalised nutrition intervention will be developed through a Smart Personalised Nutrition (SPN) service using a randomised controlled trial targeting gut microbiota (GM) composition and functio
Sponsors
University of Granada
Institute of Food Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study population 1 (normal-weight and overweight adults): 1. Age 20 - 65 years 2. Apparently healthy 3. BMI 20-28 kg/m² 4. Weight stable 5. Use of smartphone 6. Internet connection Study population 2: 1. BMI =95 percentile for age, gender and height, males 6-11 years, females 6-11 years 2. Diagnosed with celiac disease, aged 6-11 years, on elimination (gluten-free) diet and allergic to gluten (very few), on elimination (gluten-free) diet 3. Age males 6-11-years, females 6-11 years and one of the following: 3.1. IgE-mediated milk allergy, on elimination diet from infancy 3.2. Lactose intolerance (symptoms plus breath hydrogen positive test) 3.3. Overgrown IgE-mediated milk allergy but current aversion for milk 3.4. Nondefinable phenotype (children who avoid milk but do not belong to any of the previous phenotypes) 4. BMI >5th and 5th and <85th percentile for age, gender, and height, age: males 5-11 years, females 5-11 years
Exclusion criteria
Exclusion criteria: Study population 1 (normal-weight and overweight adults): 1. Diagnosis of chronic GI disorders, diabetes, celiac disease, or chronic diseases 2. Present pregnancy or lactation (10 h/week) 8. Alcohol consumption >21 drinks/week for men and >14 drinks/week for women Study population 2: 1. GI disease, endocrinopathies, probiotics in the last 2 weeks 2. Never symptoms 3. Other gastrointestinal comorbidities 4. Chronic GI disorders, any other chronic disease, elimination diet, probiotics in the last 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Variation in alpha diversity determined by 16S gene-targeted sequencing at baseline and 12 weeks 2. Consumer empowerment through technology adoption and long-lasting adoption of healthy and sustainable diet, measured using questionnaire and Food Frequency Questionnaire (FFQ) at baseline, 12 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Food intake measured using FFQ and nutritional app at baseline and 12 weeks 2. Body weight self-measured using a scale at baseline, 4, 8, 12, 24 weeks 3. Blood pressure self-measured using a sphygmomanometer at baseline, 4, 8, 12, 24 weeks 4. Body composition, physical activity levels and sleep duration measured using a wearable band at baseline, 4, 8, 12, 24 weeks 5. Short-chain fatty acids and secondary bile acids in faeces measured using targeted metabolomics by means of mass spectrometry at baseline and 12 weeks 6. Urine metabolomics measured using an in vitro metabolomics diagnostic test at baseline and 12 weeks | — |
Countries
Germany, Greece, Spain
Contacts
Public ContactFabio;José Ángel Lauria;Rufián Henares
;
Outcome results
None listed