Healthy Adult Participants, Healthy Adult Subject, Healthy Adult Volunteer, Healthy Participants, Healthy Subjects
Conditions
Keywords
Snacks, Snack foods, Dietary intervention, Hunger, Health, Wellbeing, Nutrition study, Microbiome
Brief summary
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 5-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 5 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
Detailed description
Diet, and snacking behaviour in particular, plays an important role in long-term health. Snacking now contributes substantially to daily energy intake in the UK and US: data from the ZOE PREDICT study show that 95% of adults snack at least once a day, with snacks accounting for around a quarter of daily energy intake (2.28 snacks/day). However, the average UK snack has a poor nutrient profile, high in refined carbohydrates, added sugars, and saturated fat, and low in fibre and micronutrients, a pattern linked to poorer cardiometabolic health. Despite public health guidance to consume at least 30g of fibre a day, UK adults consume an average of around 20g/day. However, the composition and timing of a snack are important determinants of its effects on hunger, energy, and other health markers. This trial evaluates an intervention (2 x snack bars) against a control (2 x snack bars that reflect the average nutrient profile of snacks currently sold in the UK). Using a control snack bar means any effects observed can be attributed to the specific formulation of the intervention snack bar, rather than simply to a change in snacking habits or a reduction in overall snack consumption. The primary aim of the study is to determine whether the intervention snack bars reduce subjective daily hunger over 5 weeks of daily use, compared with control snack bars representative of the average UK snack nutrient profile. The study will be conducted in 2 phases. In this phase (phase 2; chronic randomised controlled trial), 100 participants (50 per arm) will eat the intervention or control bars daily for 5 weeks. Secondary aims for this phase include the bar's effects on gut microbiome composition, gastrointestinal symptoms, bowel habits (frequency and consistency), subjective mood and energy, sleep quality, and anthropometric measures. The design allows the chronic effects of the intervention snack bars to be assessed when the bars are eaten regularly in place of habitual snack foods.
Interventions
High-fibre plant-based snack bars.
OTHERControl snack bars
Commercially available snack bars (UK); reflects the energy and macronutrient profile of a typical UK snack.
Sponsors
Zoe Global Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be masked to the intervention of interest in both phases of the trial. Intervention and control snack bars will be provided in identical, neutral packaging and labelling (incl. allergens), referred to only by a product code, and no participant-facing material or communication with study staff will identify which treatment is the intervention of interest. Analysts will be blinded to treatment allocation via coding of the interventions/control in analysis datasets.
Intervention model description
A parallel design 5-week randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily hunger | 2-hourly intervals for 3 days, at baseline and week 5 of the intervention. | Subjective hunger ratings, assessed using digital visual analogue scales (VAS; 0-100), with anchor points 0 = 'not at all hungry', 100 = 'extremely hungry'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome composition | Baseline, week 5 of the intervention. | Relative abundance of selected microbiome species (those included in the ZOE microbiome-health ranks 2025 \& ZOE microbiome-diet ranks 2025), derived from metagenomic analysis of stool samples. |
| Weight | Baseline, week 5 of the intervention. | Self-reported body weight (kg). |
| Body mass index (BMI) | Baseline, week 5 of the intervention. | BMI (kg/m2) calculated from self-reported body weight (kg) and height (cm). |
| Waist & Hip circumference | Baseline, week 5 of the intervention. | Self-reported waist and hip circumference (cm). |
| Gastrointestinal symptoms | Baseline, week 5 of the intervention. | Subjective gastrointestinal symptoms, assessed using the Gastrointestinal Symptoms Ratings Scale. Participants rate symptoms on a 7-point scale ranging from 'no discomfort' to 'severe discomfort'. |
| Stool frequency | Baseline, week 5 of the intervention. | Self-reported stool frequency (bowel movements per week) assessed via online questionnaire. |
| Stool consistency | Baseline, week 5 of the intervention. | Self-reported stool consistency assessed via the Bristol Stool Form Scale. Participants rate their average stool consistency on a 7-point scale. |
| Satiety | Baseline (3-days), week 5 of the intervention (3-days) | Subjective satiety ratings, assessed using digital visual analogue scales (VAS; 0-100), with anchor points 0 = 'not at all', 100 = 'extremely'. |
| Subjective energy, mood & alertness | Baseline (3-days), week 5 of the intervention (3-days) | Subjective ratings of energy, mood and alertness, assessed using digital visual analogue scales (VAS; 0-100), with anchor points 0 = 'not at all', 100 = 'extremely'. |
| Sleep | Baseline, week 5 of the intervention. | Self-reported sleep quality, assessed using the Pittsburgh Sleep Quality Index. Scores range from 0-6, with higher scores indicating poor sleep quality. |
| Energy and nutrient intake | Baseline (3-days), week 5 of the intervention (3-days). | Energy (kcal) and nutrient intake (g/day; %EI), assessed using digital food log (myFood24). |
Countries
United Kingdom
Contacts
CONTACTStudy Co-ordinator
PRINCIPAL_INVESTIGATORBerry E Sarah, Professor
King's College London
Outcome results
None listed