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OpenTrials
Completed

NCT Number: NCT06333184

Smoothies and Blood Sugars

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Food

Other

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

Primary outcomes

  1. Glycaemic index of product with capillary vs CGM

    Time frame: 120 min

    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.

Secondary outcomes

  1. Glycaemic index of all conditions with capillary vs CGM

    Time frame: 120 min

    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.

Other outcomes

  1. Condition-by-sampling interaction

    Time frame: 120 min

    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.

  2. GI of products in capillary samples

    Time frame: 120 min

    Comparisons between conditions for the 2-hour incremental area under the curve relative to CONTROL using capillary blood glucose.

  3. GI of products in continuous glucose monitors

    Time frame: 120 min

    Comparisons between conditions for the 2-hour incremental area under the curve relative to CONTROL using continuous glucose monitors.

  4. Peak glucose capillary vs CGM

    Time frame: 120 min

    The condition-by-blood sampling interaction for the postprandial peak glucose concentrations (mmol/L)

  5. Time to peak glucose capillary vs CGM

    Time frame: 120 min

    The condition-by-blood sampling interaction for the time to peak glucose concentrations (min)

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Official study title

Examining the Blood Sugar Response to Fruit Smoothie Consumption

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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