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Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study (SMARTEATS-PP)

21. august 2026 opdateret af: Zoe Global Limited

The ZOE SMART EATS (Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks) Acute Postprandial Study: Investigating the Acute Effects of a High-fibre Plant-based Snack Bar on Subjective Postprandial Hunger, Energy Intake and Eating Behaviour in Healthy UK Adults.

The goal of this clinical trial is to learn how eating different snack foods affects acute hunger, energy intake and eating behaviour in healthy adults. The study will be conducted remotely over 5 days.

The main questions it aims to answer are:

  1. Does eating a snack bar intervention change how hungry participants feel later in the same day?
  2. Does eating a snack bar intervention change participants' energy intake, nutrient intake and eating behaviour on the same day?
  3. Does eating a snack bar intervention change participants mood, energy levels and alertness later in the same day?

Researchers will compare an intervention snack bar to a control snack bar to see if the intervention improves hunger, energy intake, eating behaviour, and other subjective measures.

Participants will:

  • Eat 2 snack bars for breakfast on 2 separate days, with 2 days in between
  • Not eat anything after 9pm the night before each test day
  • Fill out short online surveys (under 5 minutes) before breakfast and at set times over the next 3 hours
  • Not eat for 3 hours after breakfast
  • Write down everything they eat that day

Studieoversigt

Detaljeret beskrivelse

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 postprandial hunger (in the hours after eating them), compared with control snack bars broadly representative of the average UK snack nutrient profile. The study will be conducted in 2 phases. In this phase (phase 1; acute postprandial study), 54 participants will complete a crossover postprandial study measuring hunger, satiety, mood, energy, and alertness over 3 hours, and as an end of day measure following consumption of the intervention or control; as well as eating behaviour and subsequent energy and nutrient intake on that day. The postprandial design allows the acute, within-day effects of the intervention snack bars to be assessed under tightly controlled conditions.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

54

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
Breakfast test meal consisting of 2 x intervention snack bars
A high-fibre plant-based snack bar.
Placebo komparator: Control
Breakfast test meal consisting of 2 x control snack bars
Commercially available snack bars (UK); reflects the energy and macronutrient profile of a typical UK snack.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postprandial hunger
Tidsramme: Within 3 hours post-test meal consumption.
Assessed using digital visual analogue scales (VAS; 0-100) with anchor points 0 = 'not at all hungry', 100 = 'extremely hungry'. Completed at pre-specified time points immediately before and during a 3h post-meal fast.
Within 3 hours post-test meal consumption.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postprandial satiety
Tidsramme: Within 3 hours post-test meal consumption.
Subjective postprandial satiety ratings, assessed using digital visual analogue scales (VAS; 0-100), with anchor points 0 = 'not at all', 100 = 'extremely'. Completed at pre-specified time points immediately before and during a 3h post-meal fast.
Within 3 hours post-test meal consumption.
Postprandial mood and energy
Tidsramme: Within 3 hours post-test meal consumption.
Subjective postprandial ratings of mood and energy, assessed using digital visual analogue scales (VAS; 0-100), with anchor points 0 = 'not at all', 100 = 'extremely'. Completed at pre-specified time points immediately before and during a 3h post-meal fast.
Within 3 hours post-test meal consumption.
Eating rate
Tidsramme: Duration of test meal consumption (day 1, day 4).
Self-reported eating rate (g/min) of the intervention and control test meals. Derived from the amount of food consumed (g) and self-reported eating duration (mins)
Duration of test meal consumption (day 1, day 4).
Time to next meal
Tidsramme: Anticipated 3-6 hours post-test meal consumption (day 1, day 4).
Self-reported time to next meal (mins) following the test meals.
Anticipated 3-6 hours post-test meal consumption (day 1, day 4).
Energy and nutrient intake
Tidsramme: Post-3 hour fast to midnight (day 1, day 4).
Energy (kcal) and nutrient intake (g; %EI) following the test meals. Assessed using digital food log (myFood24).
Post-3 hour fast to midnight (day 1, day 4).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. august 2026

Primær færdiggørelse (Anslået)

16. september 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

13. august 2026

Først indsendt, der opfyldte QC-kriterier

19. august 2026

Først opslået (Faktiske)

20. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ZOE SMART EATS - Postprandial

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Starting 6 months after publication.

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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