A new way to develop a smart personal nutrition system

Not Applicable

Completed

• Conditions: utrition and lifestyle; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN63745549
• Lead Sponsor: niversity of Granada

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35627049/ (added 31/05/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-20
• Study Completion: 2023-03-31
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 408

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 <85th percentile for age, gender, and height, age: males 6-11 years, females 6-11 years

Updated 22/07/2022:
Study population 2:
1. BMI =95 percentile for age, gender and height, males 5-11 years, females 5-11 years
2. Diagnosed with celiac disease, aged 5-11 years, on elimination (gluten-free) diet and allergic to gluten (very few), on elimination (gluten-free) diet
3. Age males 5-11 years, females 5-11 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 <85th percentile for age, gender, and height, age: males 5-11 years, females 5-11 years

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 (<6 weeks prior to study start), or planning to get pregnant
3. Recent inflammation and/or long-term use of anti-inflammatory drugs
4. Medically prescribed diet or specific dietary regimens for any reasons (i.e. high-protein diet, vegetarianism, veganism, etc)
5. Antibiotic treatment (<3 months prior to study start)
6. Intake of antioxidant, pre- or probiotic supplements (< 1 month prior to study start)
7. Intense physical activity (>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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Variation in alpha diversity determined by 16S gene-targeted sequencing at baseline and 12 weeks<br>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 Outcome Measures

Name	Time	Method
1. Food intake measured using FFQ and nutritional app at baseline and 12 weeks<br>2. Body weight self-measured using a scale at baseline, 4, 8, 12, 24 weeks<br>3. Blood pressure self-measured using a sphygmomanometer at baseline, 4, 8, 12, 24 weeks<br>4. Body composition, physical activity levels and sleep duration measured using a wearable band at baseline, 4, 8, 12, 24 weeks<br>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<br>6. Urine metabolomics measured using an in vitro metabolomics diagnostic test at baseline and 12 weeks