Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study (SMARTEATS-PP)
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:
- Does eating a snack bar intervention change how hungry participants feel later in the same day?
- Does eating a snack bar intervention change participants' energy intake, nutrient intake and eating behaviour on the same day?
- 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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Study Co-ordinator
- 電話番号：+44 (0)330 818 8669
- メール：smarteats-trial@joinzoe.com
研究場所
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London、イギリス
- 募集
- ZOE limited
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コンタクト：
- Study Co-ordinator
- 電話番号：+44 (0)330 818 8669
- メール：smarteats-trial@joinzoe.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Intervention
Breakfast test meal consisting of 2 x intervention snack bars
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A high-fibre plant-based snack bar.
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プラセボコンパレーター：Control
Breakfast test meal consisting of 2 x control snack bars
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Commercially available snack bars (UK); reflects the energy and macronutrient profile of a typical UK snack.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postprandial hunger
時間枠：Within 3 hours post-test meal consumption.
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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.
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Within 3 hours post-test meal consumption.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postprandial satiety
時間枠：Within 3 hours post-test meal consumption.
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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.
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Within 3 hours post-test meal consumption.
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Postprandial mood and energy
時間枠：Within 3 hours post-test meal consumption.
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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.
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Within 3 hours post-test meal consumption.
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Eating rate
時間枠：Duration of test meal consumption (day 1, day 4).
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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)
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Duration of test meal consumption (day 1, day 4).
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Time to next meal
時間枠：Anticipated 3-6 hours post-test meal consumption (day 1, day 4).
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Self-reported time to next meal (mins) following the test meals.
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Anticipated 3-6 hours post-test meal consumption (day 1, day 4).
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Energy and nutrient intake
時間枠：Post-3 hour fast to midnight (day 1, day 4).
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Energy (kcal) and nutrient intake (g; %EI) following the test meals.
Assessed using digital food log (myFood24).
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Post-3 hour fast to midnight (day 1, day 4).
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Berry E Sarah, Professor、King's College London
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- ZOE SMART EATS - Postprandial
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ANALYTIC_CODE
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