Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study (SMARTEATS-RCT)
9 września 2026 zaktualizowane przez: 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
Przegląd badań
Status
Rekrutacyjny
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
100
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Study Co-ordinator
- Numer telefonu: +44 (0)330 818 8669
- E-mail: smarteats-trial@joinzoe.com
Lokalizacje studiów
-
-
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London, Zjednoczone Królestwo
- Rekrutacyjny
- ZOE limited
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Kontakt:
- Study Co-ordinator
- Numer telefonu: +44 (0)330 818 8669
- E-mail: smarteats-trial@joinzoe.com
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
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|
Komparator placebo: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Daily hunger
Ramy czasowe: 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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Microbiome composition
Ramy czasowe: 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
Ramy czasowe: Baseline, week 5 of the intervention.
|
Self-reported body weight (kg).
|
Baseline, week 5 of the intervention.
|
|
Body mass index (BMI)
Ramy czasowe: 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
Ramy czasowe: Baseline, week 5 of the intervention.
|
Self-reported waist and hip circumference (cm).
|
Baseline, week 5 of the intervention.
|
|
Gastrointestinal symptoms
Ramy czasowe: 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.
|
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Stool frequency
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
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Energy and nutrient intake
Ramy czasowe: 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).
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Treatment acceptability
Ramy czasowe: Week 5 of the intervention.
|
Acceptability of intervention and control treatments, assessed via online questionnaire at endpoint.
|
Week 5 of the intervention.
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Berry E Sarah, Professor, King's College London
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
14 sierpnia 2026
Zakończenie podstawowe (Szacowany)
21 listopada 2026
Ukończenie studiów (Szacowany)
1 grudnia 2026
Daty rejestracji na studia
Pierwszy przesłany
13 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
24 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
14 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 września 2026
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- ZOE SMART EATS - Chronic
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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.
Ramy czasowe udostępniania IPD
Starting 6 months after publication.
Kryteria dostępu do udostępniania 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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .