Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study

The ZOE SMART EATS (Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks) Chronic Randomised Controlled Trial: Investigating the Chronic Effects of a High-fibre Plant-based Snack Bar on Subjective Daily Hunger, the Gut Microbiome and Gastrointestinal Symptoms in Healthy UK Adults.

The goal of this clinical trial is to learn how eating different snack foods affects long term hunger and gut health in healthy adults. The study will be conducted remotely over 7 weeks.

The main questions it aims to answer are:

1. Does eating a snack bar intervention for 4-weeks change how hungry participants feel throughout the day compared to a control?
2. Does eating a snack bar intervention change gut microbiome, bowel habits, digestive symptoms, and other health measures compared to a control over 4 weeks?

Researchers will compare an intervention snack bar to a control snack bar to see if the intervention improves hunger, gut microbiome, digestive symptoms and other health measures.

Participants will:

• Eat 2 snack bars in place of their usual snacks every day for 4 weeks
• Complete health measurements at the start and end of the study: a health questionnaire, 3-day food diary, 3-day hunger & satiety survey, body measurements, and a stool sample
• Fill out a short online survey (under 5 minutes) once a week

Inclusion Criteria:

• Willing and able to follow the study protocol
• Willing and able to provide informed consent
• Regular consumption of snacks (≥2 per day)
• Fibre intake <20 g/d
• Living in the UK

Exclusion Criteria:

• Have BMI of less than 18.5 kg/m² or more than 40 kg/m²
• Have an allergy or intolerance to ingredients in the intervention or control snack bars (including inulin) or cannot eat the food products safely and comfortably for any reason
• Have a personal medical history of inflammatory bowel disease, coeliac disease, Crohn's disease, irritable bowel syndrome, chronic constipation, or chronic diarrhoea
• Have started a new supplement in the past month, or are unwilling to maintain current supplement use throughout the study
• Previously purchased any ZOE products (including Daily30, ZOE gut health bar or ZOE app membership).
• Have taken any medication or product that may modify the measured study outcomes, in the past 3 months (including but not limited to: fibre supplements, antibiotics, non-topical steroids or other immunosuppressive medicines, probiotics or prebiotics, metformin, GLP-1 receptor agonists, lipid-lowering medications such as fibrates, statins, PCSK9 inhibitors, non-steroidal anti-inflammatory drugs)
• Have used opiate pain medication or a proton pump inhibitor for 8 or more consecutive days during the past 3 months
• Have experienced a heart attack, stroke or major surgery in the last 2 months
• Have received treatment for cancer in the last 3 months
• Are currently pregnant, breastfeeding or planning a pregnancy
• Are diagnosed with an eating disorder, type 1 diabetes mellitus or type 2 diabetes mellitus