- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06898840
Establishing the Glycaemic Index of Fruit Drinks Using Different Measurement Methodologies
May 6, 2026 updated by: Emma Greatorex Brooks, University of Bath
Study to Examine Glycaemic Responses to the Ingestion of Fruit Juices and Smoothies Using Different Measurement Methodologies.
Glycaemic responses to carbohydrates ingested as fruit sugars may vary depending on factors inherent to the fruit and the type of sugar.
The aim of this project is to investigate the glycaemic responses to a range of commercially available fruit drinks and to establish the glycaemic index for each product relative to a glucose reference.
Differences in recorded responses could also be influenced by the sample type (capillary blood vs interstitial fluid) and participant characteristics.
Participants will ingest 8 test drinks including 5 different fruit drinks (OJ, AJ, S&B, ENERGISE, BLUE), each matched for carbohydrate to the glucose reference (CONTROL) which will be sampled two times, an additional sample of one of the smoothies (S&B) will also be replicated.
Fingerstick capillary blood sampling alongside dual sited continuous glucose monitors (CGM) will measure glucose and lactate concentrations, subjective appetite sensations will also be recorded.
The tests will follow best practice guidelines for glycaemic index testing.
These data will provide insight into how differing formulations can alter the glycaemic responses to fruit drinks, and whether sampling technique can affect the interpretations of measurement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bath, United Kingdom, BA2 7AY
- Department for Health, University of Bath
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: CONTROL
50 g glucose (55 g dextrose powder accounting for hydration) plus 641 mL water
|
Commercially available fruit drinks or smoothies
|
|
Active Comparator: REPLICATE CONTROL
50 g glucose (55 g dextrose powder accounting for hydration) plus 641 mL water
|
Commercially available fruit drinks or smoothies
|
|
Experimental: S&B
417 mL of commercially available "Strawberries & Bananas" fruit smoothie providing 50 g carbohydrate [strawberries (31%), apples, bananas (22%), white grapes, oranges, blackcurrants].
Plus 224 mL water to standardise volume
|
Commercially available fruit drinks or smoothies
|
|
Experimental: REPLICATE S&B
417 mL of commercially available "Strawberries & Bananas" fruit smoothie providing 50 g carbohydrate [strawberries (31%), apples, bananas (22%), white grapes, oranges, blackcurrants].
Plus 224 mL water to standardise volume
|
Commercially available fruit drinks or smoothies
|
|
Experimental: OJ
641 mL of commercially available "Smooth Orange Juice" providing 50 g of carbohydrate [100% oranges]
|
Commercially available fruit drinks or smoothies
|
|
Experimental: AJ
455 mL commercially available "Apple Juice" providing 50 g of carbohydrate [apples, ascorbic acid].
Plus 186 mL water to standardise volume
|
Commercially available fruit drinks or smoothies
|
|
Experimental: ENERGISE
417 mL of commercially available "Energise Super Smoothie" providing 50 g carbohydrate [apples (50%), red grapes, bananas, strawberries (10%), blackcurrants, sour cherries (3.3%), pressed beetroot, flax seeds (0.56%), guarana infusion (0.01%), vitamins B1, B2, B3, B6, C & E].
Plus 224 mL water to standardise volume
|
Commercially available fruit drinks or smoothies
|
|
Experimental: BLUE
521 mL of commercially available "Bolt from the Blue" juice drink providing 50 g carbohydrate [apple (66%), coconut water (18%), white grapes, white guava (5.2%), passion fruit, lime (0.87%), spirulina extract (0.81%) vitamins B1, B2, B3, B6, C & E].
Plus 120 mL water to standardise volume
|
Commercially available fruit drinks or smoothies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycaemic indices for 5 test drinks measured using capillary blood samples
Time Frame: 120 minutes
|
Glycaemic indices [2-hour incremental area under the glucose curve (mmol/L-1x120 minutes) for each of the 5 test drinks relative to mean value of control conditions (CONTROL, REPLICATE CONTROL), expressed as a percentage] in capillary blood samples
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycaemic index of all conditions with capillary blood samples vs CGM
Time Frame: 120 minutes
|
The difference in glycaemic index [2-hour incremental area under the glucose curve (mmol/L-1x120 minutes) for 5 test drinks relative to mean control (CONTROL, REPLICATE CONTROL), expressed as a percentage] in capillary blood samples versus continuous glucose monitors.
|
120 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparisons between conditions in glucose concentration in capillary samples
Time Frame: 120 minutes
|
Comparison of blood glucose concentration 2-hour incremental area under the curve (iAUC) min.mmol/L
between test conditions
|
120 minutes
|
|
Comparisons between conditions in glucose concentration in capillary samples
Time Frame: 120 minutes
|
Comparison of postprandial peak concentration mmol/L of blood glucose between test conditions (Cmax)
|
120 minutes
|
|
Comparisons between conditions in glucose concentration in capillary samples
Time Frame: 120 minutes
|
Comparison of time to peak blood glucose concentration in minutes (Tmax) between test conditions
|
120 minutes
|
|
Comparisons between conditions in glucose concentration in capillary samples
Time Frame: 120 minutes
|
Comparison of blood glucose concentration mmol/L at 2 hours between test conditions
|
120 minutes
|
|
Comparisons between conditions in glucose concentration with CGM
Time Frame: 120 minutes
|
Comparison of glucose concentration 2-hour incremental area under the curve (iAUC) min.mmol/L
between test conditions
|
120 minutes
|
|
Comparisons between conditions in glucose concentration with CGM
Time Frame: 120 minutes
|
Comparison of postprandial peak concentration mmol/L of glucose between test conditions (Cmax)
|
120 minutes
|
|
Comparisons between conditions in glucose concentration with CGM
Time Frame: 120 minutes
|
Comparison of time to peak glucose concentration in minutes (Tmax) between test conditions
|
120 minutes
|
|
Comparisons between conditions in glucose concentration with CGM
Time Frame: 120 minutes
|
Comparison of glucose concentration mmol/L at 2 hours between test conditions
|
120 minutes
|
|
Comparisons between conditions in lactate concentration in capillary samples
Time Frame: 120 minutes
|
Comparison of blood lactate concentration 2-hour incremental area under the curve (iAUC) min.mmol/L
between test conditions
|
120 minutes
|
|
Comparisons between conditions in lactate concentration in capillary samples
Time Frame: 120 minutes
|
Comparison of postprandial peak concentration mmol/L of blood lactate between test conditions (Cmax)
|
120 minutes
|
|
Comparisons between conditions in lactate concentration in capillary samples
Time Frame: 120 minutes
|
Comparison of time to peak blood lactate concentration in minutes (Tmax) between test conditions
|
120 minutes
|
|
Comparisons between conditions in lactate concentration in capillary samples
Time Frame: 120 minutes
|
Comparison of blood lactate concentration mmol/L at 2 hours between test conditions
|
120 minutes
|
|
Comparisons between conditions of appetite ratings
Time Frame: 120 minutes
|
Comparison of subjective appetite sensations assessed with visual analogue scales (2-hour area under the curve min.mmVAS)
|
120 minutes
|
|
Comparisons between individuals
Time Frame: 120 minutes
|
Comparison of Postprandial lactate concentration min.mmol/L
between individuals 2-hour incremental area under curve (iAUC)
|
120 minutes
|
|
Comparisons between individuals
Time Frame: 120 minutes
|
Comparison of Postprandial glucose concentration min.mmol/L
between individuals 2-hour incremental area under curve (iAUC)
|
120 minutes
|
|
Comparisons between individuals
Time Frame: 120 minutes
|
Comparison of Appetite rating responses min.mmVAS
between individuals 2-hour area under curve (AUC)
|
120 minutes
|
|
Comparisons within individuals
Time Frame: 120 minutes
|
Comparison within individuals of interstitial glucose concentrations measurements from continuous glucose monitors on left and right arms.
|
120 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2025
Primary Completion (Actual)
July 9, 2025
Study Completion (Actual)
July 9, 2025
Study Registration Dates
First Submitted
February 28, 2025
First Submitted That Met QC Criteria
March 20, 2025
First Posted (Actual)
March 27, 2025
Study Record Updates
Last Update Posted (Actual)
May 11, 2026
Last Update Submitted That Met QC Criteria
May 6, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7134-9931
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
These will become available at the point of publication permanently
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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