An interventional study of Food in Metabolic Disturbance, sponsored by University of Bath. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Bath · Not applicable, Interventional, and Basic science
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.
University of Bath is the lead sponsor of 91 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 g glucose (55 g dextrose powder accounting for hydration) plus 417 mL water
Other: Food
417 mL of commercially available "Mango \& Passion fruit" fruit smoothie providing 50 g carbohydrate
Other: Food
Apples (51%), Mango (16%), Banana (16%), Orange (12%), Passionfruit (3%), Peach (2%), Lime (0.4%; recipe matched to PRODUCT) eaten as whole fruit with added water as needed to match volume.
Other: Food
Apples (51%), Mango (16%), Banana (16%), Orange (12%), Passionfruit (3%), Peach (2%), Lime (0.4%; recipe matched to PRODUCT) eaten as blended fruit with added water as needed to match volume.
Other: Food
417 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 50 g carbohydrate ingested slowly over 25-35 mins.
Other: Food
417 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 50 g carbohydrate with 6 g of added inulin.
Other: Food
250 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 30 g carbohydrate.
Other: Food
Fruit ingested in whole form or as either commercially available, or home-made smoothies
Glycaemic index of product with capillary vs CGM
The difference in glycaemic index \[2-hour incremental area under the curve (mmol/L-1x120 min) for PRODUCT relative to CONTROL expressed as a percentage\] in capillary blood samples versus continuous glucose monitors.
Time frame: 120 min
Glycaemic index of all conditions with capillary vs CGM
The difference in glycaemic index \[2-hour incremental area under the curve (mmol/L-1x120 min) for all other conditions (WHOLE, BLEND, SLOW, FIBRE, DOSE) relative to CONTROL expressed as a percentage\] in capillary blood samples versus continuous glucose monitors.
Time frame: 120 min
Condition-by-sampling interaction
The effect of condition-by-blood sampling (capillary vs continuous glucose monitor) interaction for the 2-hour incremental area under the curve for all conditions.
Time frame: 120 min
GI of products in capillary samples
Comparisons between conditions for the 2-hour incremental area under the curve relative to CONTROL using capillary blood glucose.
Time frame: 120 min
GI of products in continuous glucose monitors
Comparisons between conditions for the 2-hour incremental area under the curve relative to CONTROL using continuous glucose monitors.
Time frame: 120 min
Peak glucose capillary vs CGM
The condition-by-blood sampling interaction for the postprandial peak glucose concentrations (mmol/L)
Time frame: 120 min
Time to peak glucose capillary vs CGM
The condition-by-blood sampling interaction for the time to peak glucose concentrations (min)
Time frame: 120 min
Plan to share: Yes — De-identified data will be made available open access on the University of Bath Research Data Archive (RDA) at the point of publication in a peer-reviewed journal.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Bath