Proof of principle evaluation of the AI-derived CoDiet tool - a randomised controlled trial
Diet
This study is a randomised parallel, single-blinded controlled study whereby the effectiveness of personalised dietary advice (PDA) in promoting healthy eating habits will be compared to that of general dietary advice (GDA). The study will last 28 weeks (16 weeks wait for analysis to be completed and 12 weeks of intervention and will recruit 105 volunteers (70 on the PDA arm and 35 on the GDA arm). All study visits will take place at the NIHR Imperial Clinical Research Facility. Interested volunteers will be able to contact the study team using the email address on the advert. They will be sent by email the PIS to read and also a pre-screening questionnaire to fill in to assess initial eligibility in the study. The volunteers will be able to discuss further the study with the research team by email or phone. If they are still interested in the study and their answers to the eligibility questionnaire suggest they may be eligible to participate, the volunteers will attend a health screening visit. Health Screening Visit: Interested volunteers who responded to the study advert and read the PIS form will be able to attend a screening visit at the NIHR Imperial Clinical Research Facility. They will discuss the study with the research team, and will be shown how the camera and the study equipment works. If the volunteers are satisfied with all the answers they received, they will be able to sign the consent form. Following, they will have their body weight and height, waist circumference and blood pressure measured. All women of childbearing age will have a pregnancy test. The study doctor will take a blood sample to check the general health of the volunteer. The volunteers will also fill in a food preferences questionnaire and a general demographics and medical history questionnaire. The volunteers will receive the urine and stool collection kits, which they will use to provide a stool and urine sample at study visit 1. If the volunteer passes the eligibility criteria
1. Aged 18-65 years old 2. Body Mass Index (BMI) greater than or equal to 25 kg/m2 (Asian descent individuals BMI greater than or equal to 23 kg/m2) 3. Waist circumference greater than or equal to 102 cm in males and greater than or equal to 88 cm in females (Asian descent individuals: greater than or equal to 90 cm in males greater than or equal to 80 cm in females) 4. Ability to consent on their own and understand what the study involves
1. Individuals with type 2 diabetes, chronic gastrointestinal conditions such as Crohn’s disease, irritable bowel syndrome, celiac disease or ulcerative colitis, acute infectious diseases, cancer, cardiovascular diseases, and autoimmune conditions 2. Individuals who have been on antibiotics in the past three months and/or during the study duration 3. Pregnant or breastfeeding women 4. Currently participating in other clinical trials or who have participated in clinical trials in the past 3 months 5. Individuals who are undergoing medical interventions during the study