Healthy Adult Participants, Healthy Adult Subject, Healthy Adult Volunteer, Healthy Participants, Healthy Subjects
Conditions
Keywords
Snacks, Snack foods, Dietary intervention, Hunger, Health, Wellbeing, Nutrition study
Brief summary
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
Detailed description
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.
Interventions
A high-fibre plant-based snack bar.
OTHERControl snack bars
Commercially available snack bars (UK); reflects the energy and macronutrient profile of a typical UK snack.
Sponsors
Zoe Global Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be masked to the intervention of interest in both phases of the trial. Intervention and control snack bars will be provided in identical, neutral packaging and labelling (incl. allergens), referred to only by a product code, and no participant-facing material or communication with study staff will identify which treatment is the intervention of interest. Analysts will be blinded to treatment allocation via coding of the interventions/control in analysis datasets.
Intervention model description
An acute crossover postprandial test-meal challenge
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial hunger | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial satiety | 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. |
| Postprandial mood and energy | 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. |
| Eating rate | 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) |
| Time to next meal | Anticipated 3-6 hours post-test meal consumption (day 1, day 4). | Self-reported time to next meal (mins) following the test meals. |
| Energy and nutrient intake | 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). |
Countries
United Kingdom
Contacts
CONTACTStudy Co-ordinator
PRINCIPAL_INVESTIGATORBerry E Sarah, Professor
King's College London
Outcome results
None listed