ZOE BIOME Study: Biotics Influence on Microbiome Ecosystem

Launched by KING'S COLLEGE LONDON · Jan 26, 2024

Keywords

ClinConnect Summary

The ZOE BIOME Study is researching how certain dietary supplements, known as prebiotics and probiotics, can affect our gut health and overall well-being. Prebiotics are types of fiber that feed the good bacteria in our gut, while probiotics are live bacteria that can help balance our gut microbiome. The study aims to see how these supplements can improve gut health, digestive symptoms, and even markers related to heart health, especially after meals. Participants will be randomly assigned to one of three treatments, and the study will also look at how these compounds affect feelings of hunger and mood after eating.

To be eligible for this study, participants should be between 35 and 65 years old, live in the UK, and have a body mass index (BMI) between 18.5 and 40. It's important that they haven’t used ZOE Nutrition products before and can safely take the study treatments. Participants will need to complete certain tasks, including questionnaires about their diet, and will receive a study kit delivered to their home. This study is currently recruiting, and it’s a great opportunity for those interested in improving their gut health and contributing to important research in this area.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Can provide written informed consent through an electronic consent form
• • Are able and willing to comply to the study protocol
• • Are willing to complete their study tasks on specified dates (including over the Easter Holidays)
• • Have completed the PREDICT Food Frequency Questionnaire sent to them via email
• • Have not completed the ZOE Nutrition product before
• • Are willing to do any of the three treatments to which they may be allocated, and able to complete them safely
• • Have BMI between 18.5 kg/m2 and 40 kg/m2
• • Are any sex
• • Are aged between 35 and 65 years old
• • Are based in the UK for the duration of the study and can have a study kit delivered to their location
• Exclusion Criteria:
• • Cannot eat the test treatments safely and comfortably (suffer from inflammatory bowel disease, coeliac disease, Crohn's disease, irritable bowel syndrome, allergies or intolerances, chronic constipation or chronic diarrhoea)
• • Have BMI of less than 18.5 kg/m2 or more than 40 kg/m2
• • Follow a non-omnivore diet (vegan, vegetarian)
• • Have high fermented food intake at baseline for the preceding month (≥7 servings per week)
• • Have high fibre intake at baseline for the preceding month (≥20g per day)
• • Taking medication or products in the last 3 months that may modify the measured study outcomes (Antibiotics, non-topical steroids or other immunosuppressive medicines, biologics, probiotics/prebiotics, metformin, chronic use of non-steroidal anti-inflammatory drugs)
• • Have used opiate pain medicine for 8 or more days during the last 3 months
• • Have used a proton pump inhibitor for 8 or more days during the last 3 months
• • Are currently a smoker
• • Have experienced a heart attack, stroke, or major surgery in last 2 months
• • Have received treatment for cancer in the last 3 months
• • Are currently pregnant, breastfeeding or planning a pregnancy
• • Are suffering from eating disorders, type 1 or type 2 diabetes mellitus.