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Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study (SMARTEATS-RCT)

9 septembre 2026 mis à jour par: 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:

  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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention
Snack intervention (2x snack bars). To be eaten instead of regular snacks twice a day for 5 weeks.
Autre: High-fibre plant-based snack bar
High-fibre plant-based snack bars.
Comparateur placebo: Control
Control snack (2x snack bars). To be eaten instead of regular snacks twice a day for 5 weeks.
Autre: Control snack bars
Commercially available snack bars (UK); reflects the energy and macronutrient profile of a typical UK snack.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Daily hunger
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Microbiome composition
Délai: 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
Délai: Baseline, week 5 of the intervention.
Self-reported body weight (kg).
Baseline, week 5 of the intervention.
Body mass index (BMI)
Délai: 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
Délai: Baseline, week 5 of the intervention.
Self-reported waist and hip circumference (cm).
Baseline, week 5 of the intervention.
Gastrointestinal symptoms
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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).

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Treatment acceptability
Délai: Week 5 of the intervention.
Acceptability of intervention and control treatments, assessed via online questionnaire at endpoint.
Week 5 of the intervention.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Zoe Global Limited

Les enquêteurs

  • Chercheur principal: Berry E Sarah, Professor, King's College London

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 août 2026

Achèvement primaire (Estimé)

21 novembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

13 août 2026

Première soumission répondant aux critères de contrôle qualité

19 août 2026

Première publication (Réel)

24 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • ZOE SMART EATS - Chronic

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

Starting 6 months after publication.

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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