Smoothies and Blood Sugars

Metabolic Disturbance Clinical Trial

Official title:

Examining the Blood Sugar Response to Fruit Smoothie Consumption

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333184
• Other study ID #: 3085-4215
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Bath
• Contact: Javier T Gonzalez, PhD
• Phone: 0122538
• Email: j.t.gonzalez[@]bath.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Metabolic Disturbance

Intervention

Other:
• Food
Fruit ingested in whole form or as either commercially available, or home-made smoothies

Locations

Country	Name	City	State
United Kingdom	Department for Health, University of Bath	Bath

Sponsors (1)

Lead Sponsor	Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 Mar 16. doi: 10.1007/s00394-024-03365-3. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	120 min
Other	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.	120 min
Other	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.	120 min
Other	Peak glucose capillary vs CGM	The condition-by-blood sampling interaction for the postprandial peak glucose concentrations (mmol/L)	120 min
Other	Time to peak glucose capillary vs CGM	The condition-by-blood sampling interaction for the time to peak glucose concentrations (min)	120 min
Primary	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.	120 min
Secondary	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.	120 min