Clinical trial NCT06333184: Smoothies and Blood Sugars
Official title: Examining the Blood Sugar Response to Fruit Smoothie Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disturbance
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. The aim of this project is to characterise how these factors affect the glycaemic response to a commercially available fruit smoothie. Participants will ingest 7 different test drinks in a randomised, crossover design with fingerstick capillary blood sampling alongside continuous glucose monitors. Test drinks will include a glucose reference (CONTROL), the commercial product matched for carbohydrate to CONTROL (PRODUCT), equivalent carbohydrate ingested as whole fruits (WHOLE), equivalent carbohydrate ingested as blended fruits (WHOLE), equivalent carbohydrate as the commercial product ingested slowly (SLOW), equivalent carbohydrate as the commercial product ingested with additional fibre (FIBRE), and the commercial product ingested in a dose typically bought (DOSE). These data will provide insight into how the food matrix and different patterns of ingestion can alter the glycaemic response to a fruit smoothie, and how the measurement method may alter interpretations.


Eligibility criteria: Inclusion Criteria:

* Age: 18-65 years
* Body mass index 18-30 kg/m2

Exclusion Criteria:

* diagnosis of any form of diabetes
* intolerances or allergies to any of the study procedures (e.g. fructose/inulin intolerance)
* Fructose malabsorption
* Inborn errors of fructose metabolism (e.g. fructokinase deficiency, aldolase B deficiency, fructose-1,6-bisphosphatase deficiency)
* pregnant or lactating
* any condition that could introduce bias to the study (e.g. diagnoses of lipid disorders, including cardiovascular disease, or therapies that alter lipid or glucose metabolism, such as statins or niacin).

Primary outcomes:
measure: Glycaemic index of product with capillary vs CGM
timeFrame: 120 min
Secondary outcomes:
measure: Glycaemic index of all conditions with capillary vs CGM
timeFrame: 120 min
Other outcomes:
measure: Condition-by-sampling interaction
timeFrame: 120 min
measure: GI of products in capillary samples
timeFrame: 120 min
measure: GI of products in continuous glucose monitors
timeFrame: 120 min
measure: Peak glucose capillary vs CGM
timeFrame: 120 min
measure: Time to peak glucose capillary vs CGM
timeFrame: 120 min
Locations:
city: Bath
country: United Kingdom
facility: Department for Health, University of Bath
Study officials:
References:
citation: Gonzalez JT. Are all sugars equal? Role of the food source in physiological responses to sugars with an emphasis on fruit and fruit juice. Eur J Nutr. 2024 Aug;63(5):1435-1451. doi: 10.1007/s00394-024-03365-3. Epub 2024 Mar 16.