Smoothies and Blood Sugars

NCT ID: NCT06333184

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2024-08-30

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.

Conditions

Metabolic Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control

50 g glucose (55 g dextrose powder accounting for hydration) plus 417 mL water

Group Type: ACTIVE_COMPARATOR

Food

Intervention Type: OTHER

Fruit ingested in whole form or as either commercially available, or home-made smoothies

Product

417 mL of commercially available "Mango \& Passion fruit" fruit smoothie providing 50 g carbohydrate

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Fruit ingested in whole form or as either commercially available, or home-made smoothies

Whole

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.

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Fruit ingested in whole form or as either commercially available, or home-made smoothies

Blend

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.

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Fruit ingested in whole form or as either commercially available, or home-made smoothies

Slow

417 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 50 g carbohydrate ingested slowly over 25-35 mins.

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Fruit ingested in whole form or as either commercially available, or home-made smoothies

Fibre

417 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 50 g carbohydrate with 6 g of added inulin.

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Fruit ingested in whole form or as either commercially available, or home-made smoothies

Dose

250 mL of commercially available "Mango and Passionfruit" fruit smoothie providing 30 g carbohydrate.

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Fruit ingested in whole form or as either commercially available, or home-made smoothies

Interventions

Food

Fruit ingested in whole form or as either commercially available, or home-made smoothies

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bath

OTHER

Sponsor Role: lead

Responsible Party

Javier Gonzalez

Professor of Nutrition and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department for Health, University of Bath

Bath, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 38492022 (View on PubMed)

Hutchins KM, Betts JA, Thompson D, Hengist A, Gonzalez JT. Continuous glucose monitor overestimates glycemia, with the magnitude of bias varying by postprandial test and individual - a randomized crossover trial. Am J Clin Nutr. 2025 May;121(5):1025-1034. doi: 10.1016/j.ajcnut.2025.02.024. Epub 2025 Feb 26.

Reference Type: DERIVED

PMID: 40021059 (View on PubMed)

Other Identifiers

3085-4215

Identifier Type: -

Identifier Source: org_study_id