Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorZoe Global Limited

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • High-fibre plant-based snack bar

    Other intervention

    A high-fibre plant-based snack bar.

  • Control snack bars

    Other intervention

    Commercially available snack bars (UK); reflects the energy and macronutrient profile of a typical UK snack.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postprandial hunger

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.

Time frame
Within 3 hours post-test meal consumption.

Secondary outcomes

1

Postprandial satiety

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.

Time frame
Within 3 hours post-test meal consumption.
2

Postprandial mood and energy

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.

Time frame
Within 3 hours post-test meal consumption.
3

Eating rate

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 frame
Duration of test meal consumption (day 1, day 4).
4

Time to next meal

Self-reported time to next meal (mins) following the test meals.

Time frame
Anticipated 3-6 hours post-test meal consumption (day 1, day 4).

Other outcomes

Sponsors and contacts

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