Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study (SMARTEATS-RCT)
2026년 9월 9일 업데이트: 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
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
100
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Study Co-ordinator
- 전화번호: +44 (0)330 818 8669
- 이메일: smarteats-trial@joinzoe.com
연구 장소
-
-
-
London, 영국
- 모병
- ZOE limited
-
연락하다:
- Study Co-ordinator
- 전화번호: +44 (0)330 818 8669
- 이메일: smarteats-trial@joinzoe.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
위약 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Daily hunger
기간: 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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Microbiome composition
기간: 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
기간: Baseline, week 5 of the intervention.
|
Self-reported body weight (kg).
|
Baseline, week 5 of the intervention.
|
|
Body mass index (BMI)
기간: 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
기간: Baseline, week 5 of the intervention.
|
Self-reported waist and hip circumference (cm).
|
Baseline, week 5 of the intervention.
|
|
Gastrointestinal symptoms
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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).
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Treatment acceptability
기간: Week 5 of the intervention.
|
Acceptability of intervention and control treatments, assessed via online questionnaire at endpoint.
|
Week 5 of the intervention.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Berry E Sarah, Professor, King's College London
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 8월 14일
기본 완료 (추정된)
기본 완료
2026년 11월 21일
연구 완료 (추정된)
연구 완료
2026년 12월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 13일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 19일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 14일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 9일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- ZOE SMART EATS - Chronic
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Starting 6 months after publication.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .