Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study (SMARTEATS-RCT)
9 de setembro de 2026 atualizado 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
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
100
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Study Co-ordinator
- Número de telefone: +44 (0)330 818 8669
- E-mail: smarteats-trial@joinzoe.com
Locais de estudo
-
-
-
London, Reino Unido
- Recrutamento
- ZOE limited
-
Contato:
- Study Co-ordinator
- Número de telefone: +44 (0)330 818 8669
- E-mail: smarteats-trial@joinzoe.com
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention
Snack intervention (2x snack bars).
To be eaten instead of regular snacks twice a day for 5 weeks.
|
High-fibre plant-based snack bars.
|
|
Comparador de Placebo: Control
Control snack (2x snack bars).
To be eaten instead of regular snacks twice a day for 5 weeks.
|
Commercially available snack bars (UK); reflects the energy and macronutrient profile of a typical UK snack.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Daily hunger
Prazo: 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'.
|
2-hourly intervals for 3 days, at baseline and week 5 of the intervention.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Microbiome composition
Prazo: 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.
|
Baseline, week 5 of the intervention.
|
|
Weight
Prazo: Baseline, week 5 of the intervention.
|
Self-reported body weight (kg).
|
Baseline, week 5 of the intervention.
|
|
Body mass index (BMI)
Prazo: Baseline, week 5 of the intervention.
|
BMI (kg/m2) calculated from self-reported body weight (kg) and height (cm).
|
Baseline, week 5 of the intervention.
|
|
Waist & Hip circumference
Prazo: Baseline, week 5 of the intervention.
|
Self-reported waist and hip circumference (cm).
|
Baseline, week 5 of the intervention.
|
|
Gastrointestinal symptoms
Prazo: 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'.
|
Baseline, week 5 of the intervention.
|
|
Stool frequency
Prazo: Baseline, week 5 of the intervention.
|
Self-reported stool frequency (bowel movements per week) assessed via online questionnaire.
|
Baseline, week 5 of the intervention.
|
|
Stool consistency
Prazo: 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.
|
Baseline, week 5 of the intervention.
|
|
Satiety
Prazo: 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'.
|
Baseline (3-days), week 5 of the intervention (3-days)
|
|
Subjective energy, mood & alertness
Prazo: 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'.
|
Baseline (3-days), week 5 of the intervention (3-days)
|
|
Sleep
Prazo: 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.
|
Baseline, week 5 of the intervention.
|
|
Energy and nutrient intake
Prazo: Baseline (3-days), week 5 of the intervention (3-days).
|
Energy (kcal) and nutrient intake (g/day; %EI), assessed using digital food log (myFood24).
|
Baseline (3-days), week 5 of the intervention (3-days).
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Treatment acceptability
Prazo: Week 5 of the intervention.
|
Acceptability of intervention and control treatments, assessed via online questionnaire at endpoint.
|
Week 5 of the intervention.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Berry E Sarah, Professor, King's College London
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
14 de agosto de 2026
Conclusão Primária (Estimado)
21 de novembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
13 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de agosto de 2026
Primeira postagem (Real)
24 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- ZOE SMART EATS - Chronic
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Starting 6 months after publication.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .