Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic 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 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:

1. Does eating a snack bar intervention for 5-weeks change how hungry participants feel throughout the day compared to a control? 2. 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

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

Parallel

Treatments tested in this trial

  • High-fibre plant-based snack bar

    Other intervention

    High-fibre plant-based snack bars.

  • Control snack bars

    Other intervention

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

Treatment groups

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

Trial outcomes

Primary outcomes

1

Daily hunger

Subjective hunger ratings, assessed using digital visual analogue scales (VAS; 0-100), with anchor points 0 = 'not at all hungry', 100 = 'extremely hungry'.

Time frame
2-hourly intervals for 3 days, at baseline and week 5 of the intervention.

Secondary outcomes

1

Microbiome composition

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.

Time frame
Baseline, week 5 of the intervention.
2

Weight

Self-reported body weight (kg).

Time frame
Baseline, week 5 of the intervention.
3

Body mass index (BMI)

BMI (kg/m2) calculated from self-reported body weight (kg) and height (cm).

Time frame
Baseline, week 5 of the intervention.
4

Waist & Hip circumference

Self-reported waist and hip circumference (cm).

Time frame
Baseline, week 5 of the intervention.

Other outcomes

1

Treatment acceptability

Acceptability of intervention and control treatments, assessed via online questionnaire at endpoint.

Time frame
Week 5 of the intervention.
2

Microbiome composition

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. Measured in a sub-group of participants (approx. n = 20) to determine whether there are detectable changes in the gut microbiome following a short term (2-3 weeks) dietary intervention.

Time frame
Week 3 of the intervention (midpoint)

Sponsors and contacts

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