ZOE limited
London, United Kingdom
Location status: Recruiting
NCT Number: NCT07782593
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
Interested in participating?
Request Info35 year–65 year
All sexes
Interventional
Not applicable
London, United Kingdom
Location status: Recruiting
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 4 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 4 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High-fibre plant-based snack bars.
Commercially available snack bars (UK); reflects the energy and macronutrient profile of a typical UK snack.
Time frame: 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'.
Time frame: 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.
Time frame: Baseline, week 5 of the intervention.
Self-reported body weight (kg).
Time frame: Baseline, week 5 of the intervention.
BMI (kg/m2) calculated from self-reported body weight (kg) and height (cm).
Time frame: Baseline, week 5 of the intervention.
Self-reported waist and hip circumference (cm).
Time frame: 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'.
Time frame: Baseline, week 5 of the intervention.
Self-reported stool frequency (bowel movements per week) assessed via online questionnaire.
Time frame: 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.
Time frame: 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'.
Time frame: 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'.
Time frame: 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.
Time frame: Baseline (3-days), week 5 of the intervention (3-days).
Energy (kcal) and nutrient intake (g/day; %EI), assessed using digital food log (myFood24).
Time frame: Week 5 of the intervention.
Acceptability of intervention and control treatments, assessed via online questionnaire at endpoint.
Contact information is provided by the study sponsor or research team.
Zoe Global Limited
Other
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.
Acronym: SMARTEATS-RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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