Personalised nutritional advice to aid weight loss

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: Randomisation will take place once anthropometry is completed using an independent online computerized randomisation system by a member of the study team. Randomisation will be conducted at the level of the individual and will be stratified by sex, age, and waist circumference. Volunteers will be randomly allocated to one of the three groups: 1. Control group, in which volunteers will receive general advice from a dietitian about how to improve their diet 2. Personalised nutrition group, in which participants will use the PREVENTOMICS’ mobile application alongside a dietitian to receive a personalised diet plan through MetaDieta mobile application 3. Personalised plan group, in which, in addition to advice from the dietitian and a personalised diet through the use MetaDieta app and PREVENTOMICS’ app, will also receive prompts to help change food and lifestyle choices Each intervention will last for 4 months. At the start and at the end of the intervention, subjects will visit GP for health status screening, anthropometric measurements, and blood, urine, saliva, and faeces sample collection. In the collected material, analyses of genome, metabolome, and microbiome will be performed. CONDITION: Abdominal obesity ; Nutritional, Metabolic, Endocrine ; Obesity PRIMARY OUTCOME: 1. Waist circumference will be measured at baseline and 4 months SECONDARY OUTCOME: ; 1. Classic clinical biomarkers measured using Enzyme‐Linked Immunosorbent Assay (ELISA) at baseline and 4 months; 2. Metabolomics biomarkers measured using Nuclear Magnetic Resonance (NMR) and Liquid Chromatography‐Mass Spectrometry (LC/MS) at baseline and 4 months; 3. Food intake biomarkers measured using Liquid Chromatography‐Ion Mobility Spectrometry‐Quadrupole Time of Flight Mass Spectrometry (LC‐IMS‐QToF MS) at baseline and 4 months; 4. Microbiome analysis in feaces using Next Generation Sequencing (NCS) at baseline and 4 months; INCLUSION CRITERIA: 1. Aged between 18‐65 years 2. Waist circumference >94 cm for men or >80 cm for women 3. BMI between 25‐40 in kg/m2 4. Provided written informed consent
Epistemonikos ID: 3b6d3f642ad76bd56fa6c5085ee2def1378a2fe0
First added on: Aug 24, 2024