| Registry | NCT05672017 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 104 (Actual) |
| Sponsor | Bournemouth University (Other) |
| Conditions | Dietary Behaviour |
| Interventions | Dietary Instructions (Behavioral) |
| Dates | start 2023-03-01, primary completion 2024-03-31, completion 2024-12-31, first posted 2023-01-05, last updated 2025-06-26 |
| Locations | 1 site in United Kingdom |
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All trials for Dietary Behaviour All trials of Dietary Instructions
This study will assess the effects of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes.
Participants will be randomized to receive instructions to either increase, decrease or make no change to sweet food consumption for 6 days, and impacts on food preferences and intakes will be assessed at baseline and after 1 week. Preferences for sweet and non-sweet foods will be assessed during a taste test at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at a subsequent breakfast at the assessment time. Buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast will be provided ad-libitum.
A subset of participants (selected at random) (10 participants randomized to increase sweet food consumption and 10 participants randomized to decrease sweet food consumption) will also be assessed via MRI and fMRI scanning to investigate brain structure and functional connectivity.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dietary Instructions: Increase sweet food consumption | Active comparator | Behavioral: Dietary Instructions | Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be provided with clear instructions, where sweet foods will be highlighted and additional means of increasing sweet food consumption will be offered. |
| Dietary Instructions: Decrease sweet food consumption | Active comparator | Behavioral: Dietary Instructions | Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be provided with clear instructions, where sweet foods will be highlighted and means of decreasing sweet food consumption will be offered. |
| Dietary Instructions: Usual Diet | Placebo comparator | Behavioral: Dietary Instructions | Participants are asked to retain their consumption of sweet foods throughout their diet. |
Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers
Inclusion Criteria: 1. aged 18-65 years; 2. habitually consume breakfast; 3. able to provide consent and complete all study materials; 4. able to attend Bournemouth University for testing. Exclusion criteria: 1. individuals who are pregnant or breastfeeding; 2. underweight (BMI <18.5); 3. have pre-existing clinical conditions such as diabetes mellitus, eating disorders, Crohn's disease and other illness's leading to participants receiving external nutritional advice and dietary restrictions; 4. have pre-existing medical conditions affecting swallow ability, taste and smell perception; 5. currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World); 6. current smokers or have smoked within 3 months of the study start date.
| Milestone | Dietary Instructions: Increase Sweet Food Consumption | Dietary Instructions: Decrease Sweet Food Consumption | Dietary Instructions: Usual Diet |
|---|---|---|---|
| Started | 40 | 43 | 21 |
| Completed | 40 | 43 | 21 |
| Not completed | 0 | 0 | 0 |
Time frame: 1 week
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Dietary Instructions: Increase Sweet Food Consumption | 0/40 (0.0%) | 0/40 (0.0%) | 0/40 (0.0%) |
| Dietary Instructions: Decrease Sweet Food Consumption | 0/43 (0.0%) | 0/43 (0.0%) | 0/43 (0.0%) |
| Dietary Instructions: Usual Diet | 0/21 (0.0%) | 0/21 (0.0%) | 0/21 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| Bournemouth University | Bournemouth, US and Canada Only | United Kingdom |