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

9 september 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention
Snack intervention (2x snack bars). To be eaten instead of regular snacks twice a day for 5 weeks.
Ander: High-fibre plant-based snack bar
High-fibre plant-based snack bars.
Placebo-vergelijker: Control
Control snack (2x snack bars). To be eaten instead of regular snacks twice a day for 5 weeks.
Ander: Control snack bars
Commercially available snack bars (UK); reflects the energy and macronutrient profile of a typical UK snack.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Daily hunger
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Microbiome composition
Tijdsspanne: 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
Tijdsspanne: Baseline, week 5 of the intervention.
Self-reported body weight (kg).
Baseline, week 5 of the intervention.
Body mass index (BMI)
Tijdsspanne: 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
Tijdsspanne: Baseline, week 5 of the intervention.
Self-reported waist and hip circumference (cm).
Baseline, week 5 of the intervention.
Gastrointestinal symptoms
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Treatment acceptability
Tijdsspanne: Week 5 of the intervention.
Acceptability of intervention and control treatments, assessed via online questionnaire at endpoint.
Week 5 of the intervention.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Zoe Global Limited

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 augustus 2026

Primaire voltooiing (Geschat)

21 november 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

13 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 augustus 2026

Eerst geplaatst (Werkelijk)

24 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 september 2026

Laatste update ingediend die voldeed aan QC-criteria

9 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • ZOE SMART EATS - Chronic

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

Starting 6 months after publication.

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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