Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study (SMARTEATS-RCT)
9 de septiembre de 2026 actualizado por: Zoe Global Limited
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:
- Does eating a snack bar intervention for 5-weeks change how hungry participants feel throughout the day compared to a control?
- 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
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Study Co-ordinator
- Número de teléfono: +44 (0)330 818 8669
- Correo electrónico: smarteats-trial@joinzoe.com
Ubicaciones de estudio
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-
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London, Reino Unido
- Reclutamiento
- ZOE limited
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Contacto:
- Study Co-ordinator
- Número de teléfono: +44 (0)330 818 8669
- Correo electrónico: smarteats-trial@joinzoe.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention
Snack intervention (2x snack bars).
To be eaten instead of regular snacks twice a day for 5 weeks.
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High-fibre plant-based snack bars.
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Comparador de placebos: Control
Control snack (2x snack bars).
To be eaten instead of regular snacks twice a day for 5 weeks.
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Commercially available snack bars (UK); reflects the energy and macronutrient profile of a typical UK snack.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Daily hunger
Periodo de tiempo: 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'.
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2-hourly intervals for 3 days, at baseline and week 5 of the intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Microbiome composition
Periodo de tiempo: 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.
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Baseline, week 5 of the intervention.
|
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Weight
Periodo de tiempo: Baseline, week 5 of the intervention.
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Self-reported body weight (kg).
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Baseline, week 5 of the intervention.
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Body mass index (BMI)
Periodo de tiempo: Baseline, week 5 of the intervention.
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BMI (kg/m2) calculated from self-reported body weight (kg) and height (cm).
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Baseline, week 5 of the intervention.
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Waist & Hip circumference
Periodo de tiempo: Baseline, week 5 of the intervention.
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Self-reported waist and hip circumference (cm).
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Baseline, week 5 of the intervention.
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Gastrointestinal symptoms
Periodo de tiempo: Baseline, week 5 of the intervention.
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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'.
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Baseline, week 5 of the intervention.
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Stool frequency
Periodo de tiempo: Baseline, week 5 of the intervention.
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Self-reported stool frequency (bowel movements per week) assessed via online questionnaire.
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Baseline, week 5 of the intervention.
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Stool consistency
Periodo de tiempo: Baseline, week 5 of the intervention.
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Self-reported stool consistency assessed via the Bristol Stool Form Scale.
Participants rate their average stool consistency on a 7-point scale.
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Baseline, week 5 of the intervention.
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Satiety
Periodo de tiempo: Baseline (3-days), week 5 of the intervention (3-days)
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Subjective satiety ratings, assessed using digital visual analogue scales (VAS; 0-100), with anchor points 0 = 'not at all', 100 = 'extremely'.
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Baseline (3-days), week 5 of the intervention (3-days)
|
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Subjective energy, mood & alertness
Periodo de tiempo: 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'.
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Baseline (3-days), week 5 of the intervention (3-days)
|
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Sleep
Periodo de tiempo: Baseline, week 5 of the intervention.
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Self-reported sleep quality, assessed using the Pittsburgh Sleep Quality Index.
Scores range from 0-6, with higher scores indicating poor sleep quality.
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Baseline, week 5 of the intervention.
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Energy and nutrient intake
Periodo de tiempo: Baseline (3-days), week 5 of the intervention (3-days).
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Energy (kcal) and nutrient intake (g/day; %EI), assessed using digital food log (myFood24).
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Baseline (3-days), week 5 of the intervention (3-days).
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Treatment acceptability
Periodo de tiempo: Week 5 of the intervention.
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Acceptability of intervention and control treatments, assessed via online questionnaire at endpoint.
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Week 5 of the intervention.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Berry E Sarah, Professor, King's College London
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.
- Zhu Y, Blundell JE, Holschuh NM, McLean R, Menon RS. Validation of a Mobile App-Based Visual Analog Scale for Appetite Measurement in the Real World: A Randomized Digital Clinical Trial. Nutrients. 2023 Jan 7;15(2):304. doi: 10.3390/nu15020304.
- Brown R, Ware L, Gray AR, Chisholm A, Tey SL. Snacking on Almonds Lowers Glycaemia and Energy Intake Compared to a Popular High-Carbohydrate Snack Food: An Acute Randomised Crossover Study. Int J Environ Res Public Health. 2021 Oct 19;18(20):10989. doi: 10.3390/ijerph182010989.
- Kikuchi H, Yoshiuchi K, Inada S, Ando T, Yamamoto Y. Development of an ecological momentary assessment scale for appetite. Biopsychosoc Med. 2015 Jan 15;9(1):2. doi: 10.1186/s13030-014-0029-6. eCollection 2015.
- Scheer FA, Morris CJ, Shea SA. The internal circadian clock increases hunger and appetite in the evening independent of food intake and other behaviors. Obesity (Silver Spring). 2013 Mar;21(3):421-3. doi: 10.1002/oby.20351.
- Beaulieu K, Oustric P, Alkahtani S, Alhussain M, Pedersen H, Quist JS, Faerch K, Finlayson G. Impact of Meal Timing and Chronotype on Food Reward and Appetite Control in Young Adults. Nutrients. 2020 May 22;12(5):1506. doi: 10.3390/nu12051506.
- Cheon E, Mattes RD. Interindividual variability in appetitive sensations and relationships between appetitive sensations and energy intake. Int J Obes (Lond). 2024 Apr;48(4):477-485. doi: 10.1038/s41366-023-01436-9. Epub 2023 Dec 22.
- Elsworth RL, Hinton EC, Flynn AN, Merrell LH, Hamilton-Shield JP, Lawrence NS, Brunstrom JM. Development of Momentary Appetite Capture (MAC): A versatile tool for monitoring appetite over long periods. Appetite. 2024 Mar 1;194:107154. doi: 10.1016/j.appet.2023.107154. Epub 2023 Dec 9.
- Godwin N, Roberts T, Hooshmand S, Kern M, Hong MY. Mixed Nuts May Promote Satiety While Maintaining Stable Blood Glucose and Insulin in Healthy, Obese, and Overweight Adults in a Two-Arm Randomized Controlled Trial. J Med Food. 2019 Apr;22(4):427-432. doi: 10.1089/jmf.2018.0127. Epub 2019 Mar 21.
- Bermingham KM, May A, Asnicar F, Capdevila J, Leeming ER, Franks PW, Valdes AM, Wolf J, Hadjigeorgiou G, Delahanty LM, Segata N, Spector TD, Berry SE. Snack quality and snack timing are associated with cardiometabolic blood markers: the ZOE PREDICT study. Eur J Nutr. 2024 Feb;63(1):121-133. doi: 10.1007/s00394-023-03241-6. Epub 2023 Sep 15.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de agosto de 2026
Finalización primaria (Estimado)
21 de noviembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
13 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- ZOE SMART EATS - Chronic
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
To protect participant privacy, individual participant clinical data and any data that could be used to identify individuals will not be publicly available and cannot be deposited in public repositories.
In line with journal requirements, data underlying the results in the publication may be made available to bona fide researchers for reproducibility of results.
Proposals, researchers or institutions requesting data will be approved if they meet the standard criteria related to ethics, privacy and data protection regulations.
Marco de tiempo para compartir IPD
Starting 6 months after publication.
Criterios de acceso compartido de IPD
The study data can be released to bona fide researchers by submitting a research proposal approved by a subpanel of our scientific advisory board which meets once per month with independent members to assess proposals.
The data may be pseudo-anonymised or otherwise redacted to comply with the UK General Data Protection Regulation (GDPR).
Researchers will be required to enter into a GDPR data sharing agreement before data may be released.
Access request proposals should be sent to data.papers@joinzoe.com.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .